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

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096200
• Other study ID #: NCI-2009-00067
• Secondary ID: NCI-2009-00067CA
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: August 2011

Study information

• Verified date: January 2022
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2011
• Est. primary completion date: April 21, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Neoplasms
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Intervention

Drug:
• Carboplatin
Given IV
• Paclitaxel
Given IV
• Sorafenib Tosylate
Given orally

Locations

Country	Name	City	State
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	Moffitt Cancer Center	Tampa	Florida
United States	Moffitt Cancer Center at Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	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.	after 6 weeks (2 cycles)
Secondary	Evaluate the Progression-free Survival Rate	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.	up to 85 months of follow-up
Secondary	Overall Survival	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.	up to 85 months of follow-up