Ovarian Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial, peritoneal, or fallopian tube cancer.
Determine the toxicity of this treatment regimen in these patients.
Evaluate measurable disease in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox).
Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
The following histologic epithelial cell types are eligible:
Serous adenocarcinoma
Endometrioid adenocarcinoma
Mucinous adenocarcinoma
Undifferentiated carcinoma
Clear cell adenocarcinoma
Mixed epithelial carcinoma
Transitional cell
Malignant Brenner tumor
Adenocarcinoma not otherwise specified
No more than 12 weeks since diagnosis
No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
GOG 0-2
Life expectancy:
Not specified
Hematopoietic:
WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Absolute granulocyte count at least 1,500/mm^3
Hepatic:
Bilirubin no greater than 1.5 times normal
SGOT/SGPT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal
Gamma-glutamyl-transferase no greater than 3 times normal
No acute hepatitis
Renal:
Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 50 mL/min
Cardiovascular:
LVEF normal by MUGA
No unstable angina
No myocardial infarction within the past 6 months
Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months
Other:
No septicemia or severe infection
No severe gastrointestinal bleeding
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
No prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
No prior radiotherapy
Surgery:
Recovered from recent prior surgery
Other:
No prior anticancer therapy that would preclude study
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There are 8 Locations for this study
Honolulu Hawaii, 96813, United States
Iowa City Iowa, 52242, United States
Bethesda Maryland, 20892, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Galveston Texas, 77555, United States
Seattle Washington, 98109, United States
Oslo , N-031, Norway
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