A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
18 Years
N/A
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer
Trial Information
A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Outcome Description:
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.
Outcome Time Frame:
after 6 weeks (2 cycles)
Safety Issue:
No
Principal Investigator
Steven Waggoner
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Western Reserve University
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2009-00067
NCT ID:
NCT00096200
Start Date:
August 2004
Completion Date:
Related Keywords:
- Recurrent Fallopian Tube Cancer
- Recurrent Ovarian Epithelial Cancer
- Recurrent Primary Peritoneal Cavity Cancer
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms, Glandular and Epithelial
- Ovarian Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
