Trial Outcomes & Findings for Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer (NCT NCT00390611)
NCT ID: NCT00390611
Last Updated: 2014-12-22
Results Overview
The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
2 years
Results posted on
2014-12-22
Participant Flow
Participant milestones
| Measure |
Paclitaxel/Carboplatin
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
|
Paclitaxel/Carboplatin/Sorafenib
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
|
|---|---|---|
|
6 Cycles of Study Treatment
STARTED
|
42
|
43
|
|
6 Cycles of Study Treatment
COMPLETED
|
37
|
34
|
|
6 Cycles of Study Treatment
NOT COMPLETED
|
5
|
9
|
|
Maintenance Sorafenib to Month 12
STARTED
|
0
|
23
|
|
Maintenance Sorafenib to Month 12
COMPLETED
|
0
|
13
|
|
Maintenance Sorafenib to Month 12
NOT COMPLETED
|
0
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel/Carboplatin/Sorafenib
n=43 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=93 Participants
|
62 years
n=4 Participants
|
62 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=93 Participants
|
42 participants
n=4 Participants
|
85 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 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 |
Paclitaxel/Carboplatin/Sorafenib
n=43 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
|---|---|---|
|
2-year Progression-free Survival
|
40 percentage of participants
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsNumber of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (\< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a \> 50% decrease in the serum CA-125 level.
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Sorafenib
n=43 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
|---|---|---|
|
Overall Response Rate (ORR)
|
29 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 18 monthsOverall survival was measured from the date of study entry until the date of death
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Sorafenib
n=43 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
|---|---|---|
|
Overall Survival (OS)
|
36.5 months
Interval 30.9 to 43.0
|
NA months
Interval 29.7 to
Median OS and upper bound of 95% confidence interval not reached for this arm
|
SECONDARY outcome
Timeframe: 18 monthsNumber of patients experiencing treatment-related adverse events
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Sorafenib
n=43 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 Participants
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
|---|---|---|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Neutropenia
|
28 participants
|
33 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Anemia
|
29 participants
|
30 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Thrombocytopenia
|
26 participants
|
25 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Febrile neutropenia
|
3 participants
|
1 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Nausea/vomiting
|
33 participants
|
37 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Peripheral neuropathy
|
31 participants
|
28 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Fatigue
|
29 participants
|
32 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Skin rash
|
41 participants
|
3 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Diarrhea
|
22 participants
|
8 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Pain-muscle
|
12 participants
|
14 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Hypersensitivity reaction (paclitaxel)
|
6 participants
|
1 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Mucositis
|
16 participants
|
7 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Constipation
|
7 participants
|
14 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Pain-joint
|
9 participants
|
11 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Anorexia
|
9 participants
|
8 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Hand-foot syndrome
|
16 participants
|
0 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Abdominal pain
|
9 participants
|
5 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Weakness
|
7 participants
|
6 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Hypertension
|
10 participants
|
2 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Dizziness
|
6 participants
|
6 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Fever (no neutropenia)
|
6 participants
|
5 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Dehydration
|
5 participants
|
4 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Dyspnea
|
3 participants
|
5 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Headache
|
5 participants
|
3 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Edema
|
3 participants
|
2 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Hyponatremia
|
4 participants
|
0 participants
|
|
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib
Pruritus
|
3 participants
|
1 participants
|
Adverse Events
Paclitaxel/Carboplatin/Sorafenib
Serious events: 12 serious events
Other events: 43 other events
Deaths: 0 deaths
Paclitaxel/Carboplatin
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel/Carboplatin/Sorafenib
n=43 participants at risk
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 participants at risk
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43
|
4.8%
2/42
|
|
Immune system disorders
Allergic reaction
|
9.3%
4/43
|
2.4%
1/42
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43
|
7.1%
3/42
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43
|
7.1%
3/42
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43
|
7.1%
3/42
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, small bowel obstruction
|
2.3%
1/43
|
2.4%
1/42
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43
|
2.4%
1/42
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/43
|
2.4%
1/42
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/43
|
0.00%
0/42
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
1/43
|
0.00%
0/42
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/43
|
2.4%
1/42
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/43
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/43
|
0.00%
0/42
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43
|
0.00%
0/42
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, hemorrhage
|
0.00%
0/43
|
2.4%
1/42
|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
2.3%
1/43
|
0.00%
0/42
|
|
General disorders
General disorders and administration site conditions - Other, failure to thrive
|
0.00%
0/43
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/43
|
2.4%
1/42
|
|
Vascular disorders
Hypotension
|
0.00%
0/43
|
2.4%
1/42
|
|
General disorders
Infusion related reaction
|
2.3%
1/43
|
0.00%
0/42
|
|
Investigations
Investigations - Other, pancytopenia
|
0.00%
0/43
|
2.4%
1/42
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.3%
1/43
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, electrolyte imbalance
|
0.00%
0/43
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43
|
0.00%
0/42
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.3%
1/43
|
0.00%
0/42
|
Other adverse events
| Measure |
Paclitaxel/Carboplatin/Sorafenib
n=43 participants at risk
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
Paclitaxel/Carboplatin
n=42 participants at risk
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, nausea/vomiting
|
74.4%
32/43
|
83.3%
35/42
|
|
General disorders
Fatigue
|
62.8%
27/43
|
78.6%
33/42
|
|
Blood and lymphatic system disorders
Anemia
|
62.8%
27/43
|
69.0%
29/42
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
65.1%
28/43
|
66.7%
28/42
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
60.5%
26/43
|
59.5%
25/42
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
51.2%
22/43
|
59.5%
25/42
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
44.2%
19/43
|
47.6%
20/42
|
|
Skin and subcutaneous tissue disorders
Rash
|
81.4%
35/43
|
7.1%
3/42
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.2%
16/43
|
50.0%
21/42
|
|
Gastrointestinal disorders
Diarrhea
|
48.8%
21/43
|
21.4%
9/42
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.9%
12/43
|
33.3%
14/42
|
|
Gastrointestinal disorders
Constipation
|
16.3%
7/43
|
35.7%
15/42
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.3%
10/43
|
26.2%
11/42
|
|
Metabolism and nutrition disorders
Anorexia
|
20.9%
9/43
|
21.4%
9/42
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
37.2%
16/43
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.3%
7/43
|
19.0%
8/42
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43
|
28.6%
12/42
|
|
Vascular disorders
Hypertension
|
23.3%
10/43
|
4.8%
2/42
|
|
General disorders
Fever
|
11.6%
5/43
|
14.3%
6/42
|
|
Nervous system disorders
Headache
|
14.0%
6/43
|
7.1%
3/42
|
|
Gastrointestinal disorders
Mucositis
|
14.0%
6/43
|
7.1%
3/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.0%
3/43
|
11.9%
5/42
|
|
Gastrointestinal disorders
Abdominal pain
|
11.6%
5/43
|
7.1%
3/42
|
|
Immune system disorders
Allergic reaction
|
16.3%
7/43
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43
|
7.1%
3/42
|
|
Nervous system disorders
Dysgeusia
|
7.0%
3/43
|
9.5%
4/42
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, mouth ulcer
|
4.7%
2/43
|
9.5%
4/42
|
|
General disorders
Edema
|
7.0%
3/43
|
4.8%
2/42
|
|
Gastrointestinal disorders
Oral pain
|
7.0%
3/43
|
4.8%
2/42
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.3%
4/43
|
2.4%
1/42
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.0%
3/43
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
2/43
|
4.8%
2/42
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.7%
2/43
|
2.4%
1/42
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, stomatitis
|
4.7%
2/43
|
0.00%
0/42
|
Additional Information
John D. Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER