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

Brief Title

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

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

Secondary Outcome

 Evaluate the Progression-free Survival Rate

Condition

Recurrent Fallopian Tube Carcinoma

Intervention

Carboplatin

Study Arms / Comparison Groups

 Arm I (closed to accrual 10/10/2008)

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

August 2004

Completion Date

August 2011

Primary Completion Date

April 2011

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Steven Waggoner, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00096200

Organization ID

NCI-2009-00067

Secondary IDs

NCI-2009-00067

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Steven Waggoner, Principal Investigator, Case Comprehensive Cancer Center

Verification Date

August 2018