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

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Sarcoma

Treatments: Biological: sargramostim; Drug: dacarbazine; Drug: cisplatin; Drug: mitomycin C; Drug: doxorubicin hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00033644

CDR0000069308

GOG-0087K

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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