Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies|
- Reduction rate of myelosuppression [ Designated as safety issue: No ]
- Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Clinical response rate [ Designated as safety issue: No ]
- Findings at second look surgery [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||October 2006|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138242
|United States, Washington|
|Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center|
|Seattle, Washington, United States, 98111-0900|
|Principal Investigator:||Howard G. Muntz, MD||Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center|