Trial Outcomes & Findings for First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (NCT NCT01097746)
NCT ID: NCT01097746
Last Updated: 2022-10-28
Results Overview
Participants with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers treated with bevacizumab, carboplatin, and weekly paclitaxel that can tolerate at least 4 cycles of therapy regardless of delay or dose modification.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2022-10-28
Participant Flow
Recruitment Period: April 2010 to December 2013. All the recruitment was done in medical clinic setting.
Participant milestones
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
taken off study before any treatment given
|
1
|
Baseline Characteristics
First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
n=33 Participants
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
54 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsParticipants with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers treated with bevacizumab, carboplatin, and weekly paclitaxel that can tolerate at least 4 cycles of therapy regardless of delay or dose modification.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
n=33 Participants
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Number of Participants With Treatment Success
|
23 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 3 participants were not evaluable due to post surgical complications.
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. Disease progression defined by imaging or palpation of at least a 20% increase in the sum of the LD of target lesions, the appearance of one or more new lesions, or unequivocal progression of existing nontarget lesions, the date of progression will be defined as the date such lesions were first found to be progressed by imaging or palpation. Estimated the PFS with the Kaplan-Meier product-limit estimator stratified by debulking status (optimal, sub-optimal).The Cox proportional hazards regression model to assess the association of gene expression and cytokines with PFS.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
n=30 Participants
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Progression-free Survival of Optimal (RO) </= 1cm (PFS) vs Suboptimal > 1 cm
Optimal (no residual)
|
22.4 Number of months
Interval 5.4 to 32.8
|
|
Progression-free Survival of Optimal (RO) </= 1cm (PFS) vs Suboptimal > 1 cm
Optimal (<1 cm)
|
16.9 Number of months
Interval 4.8 to 30.5
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Progression-free Survival of Optimal (RO) </= 1cm (PFS) vs Suboptimal > 1 cm
Suboptimal (>1 cm)
|
16.9 Number of months
Interval 3.9 to 19.2
|
Adverse Events
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
n=33 participants at risk
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Injury, poisoning and procedural complications
Wound dehisence
|
3.0%
1/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Investigations
Neutropenia
|
3.0%
1/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Bevacizumab)
n=33 participants at risk
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
48.5%
16/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Investigations
Neutropenia
|
48.5%
16/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Investigations
Decrease Platelets
|
27.3%
9/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Investigations
Leukopenia
|
33.3%
11/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
General disorders
Fatigue
|
69.7%
23/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Gastrointestinal disorders
Constipation
|
60.6%
20/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Gastrointestinal disorders
Diarrhea
|
24.2%
8/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
General disorders
Pain
|
54.5%
18/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
69.7%
23/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Gastrointestinal disorders
Mucositis
|
33.3%
11/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Gastrointestinal disorders
Nausea
|
42.4%
14/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Nervous system disorders
Neuropathy
|
33.3%
11/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Investigations
Liver Enzymes
|
12.1%
4/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.2%
8/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Infections and infestations
Nail disorder
|
9.1%
3/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Infections and infestations
Infection
|
9.1%
3/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Vascular disorders
Flushing
|
6.1%
2/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Psychiatric disorders
Insomnia
|
6.1%
2/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
2/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 months
|
Additional Information
Dr. Anil K. Sood, MD/Professor, Gyn Onc & Reproductive Med
UT MD Anderson Cancer Center
Phone: (713) 745-5266
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place