Trial Outcomes & Findings for Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer (NCT NCT01081262)
NCT ID: NCT01081262
Last Updated: 2025-11-25
Results Overview
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Up to five years
Results posted on
2025-11-25
Participant Flow
The study was activated on 12 October 2010 and closed to patient accrual on 28 October 2013.
Participant milestones
| Measure |
Arm I (Carboplatin and Paclitaxel)
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
11
|
|
Overall Study
COMPLETED
|
13
|
13
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=13 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=13 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=13 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=11 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
20-29 years
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
4 Participants
n=28448 Participants
|
|
Age, Customized
30-39 years
|
1 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
9 Participants
n=28448 Participants
|
|
Age, Customized
40-49 years
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
7 Participants
n=28448 Participants
|
|
Age, Customized
50-59 years
|
3 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
18 Participants
n=28448 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
7 Participants
n=28448 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
4 Participants
n=28448 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
1 Participants
n=28448 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=45 Participants
|
13 Participants
n=12929 Participants
|
13 Participants
n=6349 Participants
|
11 Participants
n=4548 Participants
|
50 Participants
n=28448 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
PRIMARY outcome
Timeframe: Up to five yearsPopulation: All randomized patients
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
Outcome measures
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=13 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=13 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=13 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=11 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Overall Survival
|
37.6 months
Interval 8.8 to
Upper limit not yet reached
|
27.8 months
Interval 9.3 to
Upper limit not yet reached
|
27.7 months
Interval 4.9 to 53.6
|
55.7 months
Interval 9.9 to
Upper limit not yet reached.
|
SECONDARY outcome
Timeframe: Every cycle while on treatment, up to 5 yearsPopulation: Eligible and treated patients
Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.
Outcome measures
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=13 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=13 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=13 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=11 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Hand/Foot Syndrome
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Headache
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Hypertension
|
3 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Hypomagnesemia
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Infection
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Laryngeal Spasm
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Low Lymphocytes
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Low Mood
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Low Neutrophils
|
7 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Low platelets
|
8 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Low white Blood Cells
|
5 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Mucositis
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Nausea/Vomiting
|
8 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Oral Problems
|
3 Participants
|
2 Participants
|
4 Participants
|
9 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Other
|
4 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Other GI Problems
|
8 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Pain
|
9 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Peripheral/Sensory Neuropathy
|
11 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Pneumothorax
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Raised CA19-9
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Raised Blood Counts
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Rash
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Stomatitis
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Taste Alteration
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Urinary Problems
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Vaginal Bleeding
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Weight Gain
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Weight Loss
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Alopecia
|
11 Participants
|
1 Participants
|
9 Participants
|
5 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Anemia
|
12 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Bleeding
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Cold-like symptoms
|
2 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Fever
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Constipation
|
3 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Diarrhea
|
5 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
dyspnea
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Edema Limbs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Fatigue
|
10 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Allergic reaction
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Allergic rhinitis
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Abnormal lab values
|
8 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.Population: All Randomized Patients
Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=13 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=13 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=13 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=11 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Progression-free Survival
|
36.1 Months
Interval 2.0 to
Upper limit not yet reached
|
7.4 Months
Interval 4.5 to
Upper limit not yet reached
|
15.4 Months
Interval 4.9 to
Upper limit not yet reached
|
23.3 Months
Interval 9.1 to
Upper limit not yet reached
|
SECONDARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 yearsPopulation: All randomized patients with measurable disease
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR
Outcome measures
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=9 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=11 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=7 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=5 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Objective Tumor Response
|
22 Percentage of Participants
Interval 3.0 to 60.0
|
27 Percentage of Participants
Interval 6.0 to 61.0
|
43 Percentage of Participants
Interval 10.0 to 82.0
|
40 Percentage of Participants
Interval 5.0 to 85.0
|
SECONDARY outcome
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5Population: Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
Outcome measures
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=3 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=3 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=3 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=5 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Patient Reported Neurotoxicity
Baseline (pre-treatment)
|
16.0 units on a scale.
Standard Deviation 0.0
|
15.3 units on a scale.
Standard Deviation 1.2
|
14.3 units on a scale.
Standard Deviation 2.9
|
16.0 units on a scale.
Standard Deviation 0.0
|
|
Patient Reported Neurotoxicity
Pre-cycle 4
|
7.3 units on a scale.
Standard Deviation 4.2
|
11.8 units on a scale.
Standard Deviation 5.3
|
12.7 units on a scale.
Standard Deviation 3.5
|
5.7 units on a scale.
Standard Deviation 4.9
|
|
Patient Reported Neurotoxicity
Post cycle 6
|
6.5 units on a scale.
Standard Deviation 2.1
|
11.7 units on a scale.
Standard Deviation 4.0
|
11.0 units on a scale.
Standard Deviation 5.6
|
8.0 units on a scale.
Standard Deviation 6.3
|
|
Patient Reported Neurotoxicity
Six months post chemo
|
5.0 units on a scale.
Standard Deviation 4.2
|
—
|
11.3 units on a scale.
Standard Deviation 5.7
|
10.7 units on a scale.
Standard Deviation 2.3
|
|
Patient Reported Neurotoxicity
End of bevacizumab (BEV)
|
16.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
10.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
9.5 units on a scale.
Standard Deviation 4.9
|
11.7 units on a scale.
Standard Deviation 3.8
|
|
Patient Reported Neurotoxicity
Six months after BEV
|
10.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
10.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
9.0 units on a scale.
Standard Deviation 4.2
|
7.0 units on a scale.
Standard Deviation 9.9
|
|
Patient Reported Neurotoxicity
2 years after BEV
|
8.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
14.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
5.5 units on a scale.
Standard Deviation 4.9
|
16.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
|
Patient Reported Neurotoxicity
3 years after BEV
|
14.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
—
|
9.5 units on a scale.
Standard Deviation 4.9
|
16.0 units on a scale.
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
|
Patient Reported Neurotoxicity
4 years after BEV
|
—
|
—
|
6.5 units on a scale.
Standard Deviation 6.4
|
—
|
|
Patient Reported Neurotoxicity
5 years after BEV
|
—
|
—
|
7.5 units on a scale.
Standard Deviation 3.5
|
—
|
SECONDARY outcome
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5Population: All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL
Outcome measures
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=3 Participants
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=3 Participants
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=3 Participants
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=5 Participants
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Patient Reported Quality of Life
Baseline (pre-treatment)
|
62.6 units on a scale
Standard Deviation 12.6
|
62.3 units on a scale
Standard Deviation 29.5
|
68.7 units on a scale
Standard Deviation 9.7
|
75.4 units on a scale
Standard Deviation 15.9
|
|
Patient Reported Quality of Life
Pre-Cycle 4
|
57.5 units on a scale
Standard Deviation 4.8
|
72.9 units on a scale
Standard Deviation 16.4
|
68.7 units on a scale
Standard Deviation 2.1
|
76.0 units on a scale
Standard Deviation 12.5
|
|
Patient Reported Quality of Life
Post-Cycle 6
|
65.2 units on a scale
Standard Deviation 4.0
|
73.5 units on a scale
Standard Deviation 9.1
|
68.3 units on a scale
Standard Deviation 5.5
|
71.8 units on a scale
Standard Deviation 14.1
|
|
Patient Reported Quality of Life
Six Months Post-Chemo
|
74.1 units on a scale
Standard Deviation 14.2
|
—
|
80.3 units on a scale
Standard Deviation 12.2
|
68.7 units on a scale
Standard Deviation 29.7
|
|
Patient Reported Quality of Life
End of Bevacizumab (BEV)
|
68.9 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
53.3 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
73.0 units on a scale
Standard Deviation 22.6
|
49.9 units on a scale
Standard Deviation 31.4
|
|
Patient Reported Quality of Life
Six Months after BEV
|
54.0 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
53.0 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
87.5 units on a scale
Standard Deviation 7.8
|
70.5 units on a scale
Standard Deviation 26.2
|
|
Patient Reported Quality of Life
2 Years after BEV
|
71.7 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
56.0 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
76.3 units on a scale
Standard Deviation 15.2
|
77.0 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
|
Patient Reported Quality of Life
3 Years after BEV
|
76.4 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
—
|
80.5 units on a scale
Standard Deviation 17.7
|
76.0 units on a scale
Standard Deviation NA
Standard deviation is not presented if only one valid assessment was received.
|
|
Patient Reported Quality of Life
4 Years after BEV
|
—
|
—
|
71.5 units on a scale
Standard Deviation 24.7
|
—
|
|
Patient Reported Quality of Life
5 Years after BEV
|
—
|
—
|
78.0 units on a scale
Standard Deviation 17.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineWill be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Carboplatin and Paclitaxel)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm II (Oxaliplatin and Capecitabine)
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=13 participants at risk
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=13 participants at risk
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=13 participants at risk
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=11 participants at risk
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Nervous system disorders
Peripheral/sensory neuropathy
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Immune system disorders
Allergic reaction
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
General disorders
Bleeding
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
General disorders
Fatigue
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
General disorders
Fever
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
GI perforation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Low Neutrophils
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Low Platelets
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
18.2%
2/11 • Study treatment and up to 5 years after treatment discontinuation
|
Other adverse events
| Measure |
Arm I (Carboplatin and Paclitaxel)
n=13 participants at risk
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Oxaliplatin and Capecitabine)
n=13 participants at risk
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
n=13 participants at risk
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
n=11 participants at risk
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Investigations
Low platelets
|
61.5%
8/13 • Study treatment and up to 5 years after treatment discontinuation
|
23.1%
3/13 • Study treatment and up to 5 years after treatment discontinuation
|
38.5%
5/13 • Study treatment and up to 5 years after treatment discontinuation
|
63.6%
7/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Low White Blood Cells
|
38.5%
5/13 • Study treatment and up to 5 years after treatment discontinuation
|
38.5%
5/13 • Study treatment and up to 5 years after treatment discontinuation
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
54.5%
6/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
General disorders
Mucositis
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
27.3%
3/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • Study treatment and up to 5 years after treatment discontinuation
|
61.5%
8/13 • Study treatment and up to 5 years after treatment discontinuation
|
69.2%
9/13 • Study treatment and up to 5 years after treatment discontinuation
|
81.8%
9/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Oral problems
|
23.1%
3/13 • Study treatment and up to 5 years after treatment discontinuation
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
81.8%
9/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
General disorders
Other
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
53.8%
7/13 • Study treatment and up to 5 years after treatment discontinuation
|
63.6%
7/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Other GI Problems
|
61.5%
8/13 • Study treatment and up to 5 years after treatment discontinuation
|
46.2%
6/13 • Study treatment and up to 5 years after treatment discontinuation
|
53.8%
7/13 • Study treatment and up to 5 years after treatment discontinuation
|
63.6%
7/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
General disorders
Pain
|
69.2%
9/13 • Study treatment and up to 5 years after treatment discontinuation
|
46.2%
6/13 • Study treatment and up to 5 years after treatment discontinuation
|
53.8%
7/13 • Study treatment and up to 5 years after treatment discontinuation
|
63.6%
7/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Nervous system disorders
Peripheral/sensory Neuropathy
|
84.6%
11/13 • Study treatment and up to 5 years after treatment discontinuation
|
84.6%
11/13 • Study treatment and up to 5 years after treatment discontinuation
|
61.5%
8/13 • Study treatment and up to 5 years after treatment discontinuation
|
90.9%
10/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Raised CA19-9
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Raised Blood counts
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
23.1%
3/13 • Study treatment and up to 5 years after treatment discontinuation
|
36.4%
4/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Nervous system disorders
Taste Alteration
|
23.1%
3/13 • Study treatment and up to 5 years after treatment discontinuation
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
18.2%
2/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Renal and urinary disorders
Urinary Problems
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
18.2%
2/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
18.2%
2/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Weight Gain
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
18.2%
2/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Weight Loss
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
23.1%
3/13 • Study treatment and up to 5 years after treatment discontinuation
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
45.5%
5/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Spasm
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Low Lymphocytes
|
0.00%
0/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
0.00%
0/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Psychiatric disorders
Low Mood
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
15.4%
2/13 • Study treatment and up to 5 years after treatment discontinuation
|
7.7%
1/13 • Study treatment and up to 5 years after treatment discontinuation
|
9.1%
1/11 • Study treatment and up to 5 years after treatment discontinuation
|
|
Investigations
Low Neutrophils
|
53.8%
7/13 • Study treatment and up to 5 years after treatment discontinuation
|
38.5%
5/13 • Study treatment and up to 5 years after treatment discontinuation
|
30.8%
4/13 • Study treatment and up to 5 years after treatment discontinuation
|
63.6%
7/11 • Study treatment and up to 5 years after treatment discontinuation
|
Additional Information
Linda Gedeon on behalf of William Brady, PhD
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60