Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 3

Conditions: Endometrial Cancer

Treatments: Drug: paclitaxel; Drug: cisplatin; Biological: filgrastim; Drug: doxorubicin hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003691

CDR0000066794

GOG-0177

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.
• Compare the toxicities of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.
• Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.

Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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