Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus

• Status: Terminated
• 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. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.

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

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Doxorubicin; Liposomal doxorubicin; Mitomycin; Mitomycins; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary leiomyosarcoma (LMS) of the uterus

• Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments

• At least 1 unidimensionally measurable target lesion

• At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR

• At least 10 mm by spiral CT scan

• Tumors within a previously irradiated field are designated as non-target lesions

• Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No active infection requiring antibiotics

• No grade 2 or greater sensory or motor neuropathy

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy for LMS of the uterus

Endocrine therapy:

• At least 1 week since prior hormonal therapy for LMS of the uterus

• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics

• Recovered from prior recent radiotherapy

Surgery:

• Recovered from prior recent surgery

Other:

• Recovered from other prior recent therapy

• No prior cancer treatment that would preclude study therapy