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Status:

UNKNOWN

Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Ovarian Cancer

Eligibility:

FEMALE

18-75 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more ...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer. * Determine the toxicity of this regimen in these ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial cancer
  • Stage III or IV disease
  • Metastatic peritoneal, lymphatic, or visceral disease
  • Measurable or evaluable disease
  • Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen
  • No symptomatic brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 75
  • Performance status
  • WHO 0-2 (0 in patients 70 to 75 years of age)
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hepatic
  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN
  • Alkaline phosphatase less than 2.5 times ULN
  • Renal
  • Creatinine no greater than 1.4 mg/dL
  • Other
  • No serious uncontrolled infection
  • No intolerance to polysorbate 80
  • No peripheral neuropathy greater than grade 1
  • No neurological or mental disease that would preclude study participation
  • No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No more than 1 prior chemotherapy regimen
  • No prior oxaliplatin or docetaxel
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy
  • Surgery
  • Not specified
  • Other
  • More than 28 days since prior participation in another clinical study
  • No other concurrent anticancer treatment

Exclusion

    Key Trial Info

    Start Date :

    July 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00075543

    Start Date

    July 1 2003

    Last Update

    July 24 2008

    Active Locations (5)

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

    Page 1 of 2 (5 locations)

    1

    Intercommunal Hospital

    Montfermeil, France, 93370

    2

    Hopital Saint Antoine

    Paris, France, 75012

    3

    Hopital Tenon

    Paris, France, 75970

    4

    Polyclinique De Courlancy

    Reims, France, F-51100