Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial 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 cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma

• Very poor potential for cure by radiotherapy or surgery alone or in combination

• Measurable disease

• Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

• Granulocyte count at least 1,500/mm^3

Hepatic

• SGPT no greater than 3 times upper limit of normal

• Bilirubin normal

Renal

• Creatinine no greater than 1.6 mg/dL

Cardiovascular

• LVEF at least 50% within past 6 months

• No uncontrolled angina

• No third-degree or complete heart block unless a pacemaker is in place

Neurologic

• No serious peripheral neuropathy

Other

• No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer

• No uncontrolled infection

• No sensitivity to E. coli-derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy allowed

• No concurrent biologic therapy

Chemotherapy

• No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization

• No prior chemotherapy for any prior malignancy

Endocrine therapy

• Prior hormone therapy allowed

• No concurrent hormone therapy

Radiotherapy

• At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine

Surgery

• Not specified