Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Phase 2

Completed

Conditions: Recurrent Ovarian Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Primary Peritoneal Carcinoma

Interventions: Drug: Sorafenib Tosylate
Drug: Carboplatin
Drug: Paclitaxel

Registration Number: NCT00096200

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).

Detailed Description: PRIMARY OBJECTIVES :

I. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I \[sorafenib only\] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.

ARM I (closed to accrual 10/01/2008): Patients receive oral sorafenib twice daily on days 1-28.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II.

ARM II: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 44

Inclusion Criteria

Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
Recurrent disease
Must have received a prior platinum-based regimen
Platinum-sensitive (treatment-free interval > 6 months)
No more than 2 prior chemotherapy regimens
Measurable disease
At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
Not in a prior irradiation field
No known brain metastases
Performance status:
- ECOG 0-2 OR
- Karnofsky 80-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count >= 1,500/mm3
- Platelet count >= 100,000/mm3
- Hemoglobin >= 9 g/dL
- No bleeding diathesis
Hepatic:
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST or ALT =< 2 times ULN
No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study
Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study
No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El:
Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully
Renal:
- Creatinine < 2 mg/dL
Cardiovascular:
- Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months
- No symptomatic congestive heart failure
- No uncontrolled hypertension
- No cardiac arrhythmia
- No unstable angina pectoris;
- No myocardial infarction within the past 6 months
Negative pregnancy test
Fertile patients must use effective contraception
Adequate intestinal function
No concurrent requirements for IV hydration or nutritional support
No active or ongoing infection
No psychiatric illness or social situation that would preclude study compliance
No other concurrent uncontrolled illness
No other invasive malignancy with the past 5 years except nonmelanoma skin cancer
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
More than 3 weeks since prior hormonal therapy
More than 4 weeks since prior radiotherapy and recovered
No prior sorafenib
No prior anticancer therapy that contraindicates study therapy
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent therapeutic anticoagulation therapy
Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices
No other concurrent anticancer therapies
No other concurrent investigational agents
Not pregnant or nursing

Exclusion Criteria

Not provided

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (closed to accrual 10/10/2008)	Sorafenib Tosylate	Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
Arm II	Sorafenib Tosylate	Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II	Paclitaxel	Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II	Carboplatin	Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	after 6 weeks (2 cycles)	Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.

Secondary Outcome Measures

Name	Time	Method
Evaluate the Progression-free Survival Rate	up to 85 months of follow-up	Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
Overall Survival	up to 85 months of follow-up	Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.

Trial Locations

Locations (5): Moffitt Cancer Center at Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States
Lake University Ireland Cancer Center
🇺🇸
Mentor, Ohio, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸
Richmond, Virginia, United States

Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Recruitment & Eligibility

Study & Design

Trial Locations

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