Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction rate of myelosuppression
Safety Issue:
No
Principal Investigator
Howard G. Muntz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
Authority:
United States: Federal Government
Study ID:
VMRC-8837
NCT ID:
NCT00138242
Start Date:
December 2004
Completion Date:
October 2006
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- fallopian tube cancer
- primary peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center | Seattle, Washington 98111 |
