Phase III Randomized Study of Doxorubicin, Cisplatin, Paclitaxel, and Filgrastim (G-CSF) Versus Carboplatin and Paclitaxel in Patients With Stage III or IV or Recurrent Endometrial Cancer
Last Modified: 4/21/2009  First Published: 6/23/2003
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Treatment | Closed | 18 and over | GOG-0209 NCT00063999 |
Special Category:
CTSU trial, NCI Web site featured trial Objectives - Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer.
- Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens.
- Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients.
- Compare the quality of life of patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed endometrial carcinoma
- FIGO stage III or IV or recurrent disease
- Must know estrogen and progesterone status of the primary tumor
- Poor potential for curative treatment by radiotherapy and/or surgery
- At least 1 unidimensionally measurable lesion (for patients with stage III disease only)
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan
- Disease in a previously irradiated field acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy
Prior/Concurrent Therapy:
Biologic therapy - Prior biologic therapy allowed
- No concurrent biologic therapy
Chemotherapy - No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy
Endocrine therapy - Prior hormonal therapy allowed
- No concurrent hormonal therapy
Radiotherapy - See Disease Characteristics
- At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
- No concurrent radiotherapy
Surgery Other - Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic - Bilirubin normal
- ALT no greater than 3 times upper limit of normal
Renal - Creatinine no greater than 1.6 mg/dL
Cardiovascular - LVEF at least 50%
- Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion
- No third-degree or complete heart block without a pacemaker
- No uncontrolled angina
- No myocardial infarction within the past 6 months
- No New York Heart Association class II -IV heart failure
- No symptoms of congestive heart failure
Other - Not pregnant or nursing
- Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation
- No other invasive malignancy within the past 5 years except patients who have nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
- No serious uncontrolled infection
- No serious peripheral neuropathy
- No other concurrent medical illness that would preclude study therapy
- No circumstances that would preclude study completion or follow-up
- No sensitivity to Escherichia coli-derived drug preparations
- No uterine carcinosarcoma or other non-epithelial uterine malignancy
Expected Enrollment 900A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years. Outcomes Primary Outcome(s)Duration of overall survival
Secondary Outcome(s)Duration of progression-free survival
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. - Arm I: 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.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.
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.
Trial Contact Information
Trial Lead Organizations Gynecologic Oncology Group | | | David Miller, MD, Protocol chair | | | |
Related Information Featured trial article 1
Registry Information | | 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 | | Trial Start Date | | 2003-08-18 | | Trial Completion Date | | 2008-01-24 (estimated) | | Registered in ClinicalTrials.gov | | NCT00063999 2 | | Date Submitted to PDQ | | 2003-05-14 | | Information Last Verified | | 2009-04-21 | | NCI Grant/Contract Number | | CA27469 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
1 | http://www.cancer.gov/clinicaltrials/ft-GOG-0209 |
2 | http://clinicaltrials.gov/ct/show/NCT00063999 |
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