Status:
COMPLETED
Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
Lead Sponsor:
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Conditions:
Fallopian Tube Cancer
Ovarian 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: Primary * Determine whether weekly administration of docetaxel and carboplatin is safer than conventional three-week chemotherapy courses, in terms of reducing the rate of myelosuppressi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cavity cancer
- Stage IC-IV disease
- No borderline or low malignant potential tumors of any stage
- Underwent initial surgical management, including staging, of early stage disease or surgical debulking of advanced stage disease\* NOTE: \*Patients may delay surgical debulking, if clinically indicated, until after study entry; these patients may receive several courses of neoadjuvant chemotherapy prior to surgical debulking, but before study entry
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin normal
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No peripheral neuropathy \> grade 1
- No prior malignancy with a poor prognosis that is at risk of relapse during study participation, as determined by the principal investigator
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No concurrent chemotherapy for another malignancy
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00138242
Start Date
December 1 2004
End Date
October 1 2006
Last Update
June 26 2013
Active Locations (1)
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1
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98111-0900