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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00063999 |
RATIONALE: Drugs used in chemotherapy such as doxorubicin, cisplatin, paclitaxel, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer.
Condition | Intervention | Phase |
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Endometrial Cancer |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer |
Estimated Enrollment: | 900 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
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Biological: filgrastim
Given by injection
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
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Arm II: Experimental
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
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OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients accrued as of 04/17/06 are stratified according to disease status(measurable or recurrent disease vs non-measurable stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients with LVEF < 50% at randomization who are initially randomized to arm I are immediately crossed over to arm II.
In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma
At least 1 unidimensionally measurable lesion (for patients with stage III disease only)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | David S. Miller, MD | Simmons Cancer Center |
Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
Study ID Numbers: | CDR0000305940, GOG-0209 |
Study First Received: | July 8, 2003 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00063999 History of Changes |
Health Authority: | United States: Federal Government |
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Antimitotic Agents Carboplatin Recurrence Doxorubicin Carcinoma |
Genital Diseases, Female Anti-Bacterial Agents Endometrial Neoplasms Radiation-Sensitizing Agents Cisplatin Paclitaxel Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Paclitaxel Therapeutic Uses Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |