Overview

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