Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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