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
filgrastim
+ cisplatin
+ doxorubicin hydrochloride
Urogenital Diseases+9
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: December 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 73 locations
University of Alabama Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google MapsCCOP - Greater Phoenix
Phoenix, United StatesUSC/Norris Comprehensive Cancer Center
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United States