Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic 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/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGO Study Group
• Treatments: Carboplatin; Doxorubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer

• No ovarian epithelial cancer

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR

• Karnofsky 70-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 10.0 g/dL

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal

Renal:

• Glomerular filtration rate at least 60 mL/min

Cardiovascular:

• No atrial or ventricular arrhythmias

• No congestive heart failure even if stabilized on medication

• No New York Heart Association class III or IV heart disease

• No myocardial infarction within the past 6 months

Other:

• No pre-existing sensory or motor neuropathy grade 2 or greater

• No active infection

• No other serious medical condition that would preclude study

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

Chemotherapy:

• No more than 1 prior chemotherapy regimen for the malignancy

• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapy within the past 10 days allowed

• No concurrent hormonal therapy

Radiotherapy:

• At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow

Surgery:

• Not specified

Other:

• At least 30 days since prior experimental agents

• No other concurrent therapies that would preclude study

• No concurrent participation in another study