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BAY 43-9006 Plus Paclitaxel/Carboplatin in Women With GYN Tumors
This study is ongoing, but not recruiting participants.

First Received on November 9, 2004.   Last Updated on July 5, 2011   History of Changes
Sponsor: Case Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00096200
  Purpose

RATIONALE: 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.

PURPOSE: 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).


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: sorafenib tosylate
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • evaluate the progression-free survival rate [ Time Frame: every 6 weeks (2 cycles) ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: August 2004
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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
Drug: sorafenib tosylate
Given orally
Other Name: BAY 54-9085
Experimental: 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.
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Other Name: Taxol
Drug: sorafenib tosylate
Given orally
Other Name: BAY 54-9085

Detailed Description:

OBJECTIVES:

  • 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)
  • 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.

PROJECTED ACCRUAL: A total of 21-52 patients (9-24 for arm I [closed to accrual as of 10/10/2008] and 12-28 for arm II) will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 80-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • No bleeding diathesis

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2 times ULN

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

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate intestinal function

    • No concurrent requirements for IV hydration or nutritional support
  • 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
  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • More than 3 weeks since prior hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • 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 investigational agents
  • No other concurrent anticancer therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096200

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
UHHS Chagrin Highlands Ireland Cancer Center
Orange Village, Ohio, United States, 44122
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0034
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Steven E. Waggoner, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Waggoner, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00096200     History of Changes
Other Study ID Numbers: CASE2804, U01CA062502, P30CA043703, CASE-CWRU-2804, NCI-6557, CASE-2804
Study First Received: November 9, 2004
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
recurrent ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Sorafenib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012