Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer

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.

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