Ovarian Cancer, Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer
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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
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. * Determine the response rates (complete and partial response) in patients treated with this regimen. * Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses. After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.
Interventions
BIOLOGICALpegfilgrastim
DRUGcarboplatin
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | — |
| Response rates (complete and partial response) | — |
| Relapse rates | — |
| Event-free survival | — |
| Overall survival | — |
Countries
United States
Outcome results
None listed