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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; Liposomal doxorubicin; Paclitaxel

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