Ovarian Cancer Clinical Trial
Official title:
Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
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 ovarian epithelial, fallopian tube, or peritoneal cavity
cancer.
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
myelosuppression, in patients with stage IC-IV ovarian epithelial, fallopian tube, or
peritoneal cavity cancer.
Secondary
- Determine the quality of life of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of clinical response rate, time to
disease progression, and findings at second-look surgery, in these patients.
OUTLINE: Patients receive docetaxel IV and carboplatin IV on days 1, 8, 15. Treatment
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients may then undergo optional second-look surgery. After
completion of 6 courses of chemotherapy (and second-look surgery, if applicable), patients
may receive consolidation and/or salvage therapy at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, at the completion of
study treatment, and then annually for 2 years.
After completion of study treatment, patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
;
Masking: Open Label, Primary Purpose: Treatment
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