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Status:

COMPLETED

Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Lead Sponsor:

Fred Hutchinson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Ovarian Cancer

Peritoneal Cavity Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...

Detailed Description

OBJECTIVES: * Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse. * Determ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
  • Stage III or IV disease
  • No borderline tumors
  • Measurable or evaluable disease
  • Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
  • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
  • In first relapse
  • Platinum-sensitive disease, defined as initial relapse \> 6 months after completion of a platinum-based regimen
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Karnofsky 60-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Platelet count ≥ 100,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hepatic
  • Bilirubin normal
  • Meets 1 of the following criteria:
  • SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
  • SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
  • Renal
  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance \> 50 mL/min
  • Cardiovascular
  • LVEF ≥ 50%
  • No poorly controlled arrhythmia
  • No unstable coronary artery disease or myocardial infarction within the past year
  • Other
  • HIV negative
  • No pre-existing peripheral neuropathy \> grade 2
  • No history of allergy to study drugs
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • At least 3 weeks since prior radiotherapy and recovered
  • Surgery
  • Recovered from recent prior surgery
  • Other
  • No concurrent myelosuppressive therapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00217568

    Start Date

    May 1 2005

    Last Update

    September 21 2010

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    Pacific Gynecology Specialists

    Seattle, Washington, United States, 98104

    2

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024

    3

    University of Washington School of Medicine

    Seattle, Washington, United States, 98195