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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Fallopian Tube Carcinoma

Recurrent Ovarian Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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,...

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 w...

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2011

    Estimated Enrollment :

    44 Patients enrolled

    Trial Details

    Trial ID

    NCT00096200

    Start Date

    August 1 2004

    End Date

    August 1 2011

    Last Update

    February 8 2022

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Moffitt Cancer Center at Tampa General Hospital

    Tampa, Florida, United States, 33612

    2

    Moffitt Cancer Center

    Tampa, Florida, United States, 33612

    3

    Case Western Reserve University

    Cleveland, Ohio, United States, 44106

    4

    Lake University Ireland Cancer Center

    Mentor, Ohio, United States, 44060