|Phase III||Treatment||Closed||18 and over||NCI, Other||CDR0000305940|
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.
Further Study Information
- 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.
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.
PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.
- 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
- 18 and over
- GOG 0-2
- Not specified
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- ALT no greater than 3 times upper limit of normal
- Creatinine no greater than 1.6 mg/dL
- 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
- 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
PRIOR CONCURRENT THERAPY:
- Prior biologic therapy allowed
- No concurrent biologic therapy
- No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
- No concurrent radiotherapy
- Not specified
- Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|David Scott Miller||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00063999
ClinicalTrials.gov processed this data on October 17, 2013
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