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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: cisplatin
* Drug: doxorubicin hydrochloride
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: cisplatin|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma