Brief Title
Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
Official Title
Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
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 ovarian epithelial, fallopian tube, or peritoneal cavity
cancer.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Reduction rate of myelosuppression
Secondary Outcome
Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
December 2004
Completion Date
October 2006
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Howard G. Muntz, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00138242
Organization ID
VMRC-8837
Secondary IDs
CDR0000439927
Study Sponsor
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Study Sponsor
Howard G. Muntz, MD, Principal Investigator, Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Verification Date
October 2006