Expired Study
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Newark, New Jersey 07101


Purpose:

This study is being done on women who have cancer of the endometrium (lining of the womb), that cannot be cured with surgery or radiation therapy. In a previous study, women with an advanced stage of endometrium cancer showed improved chances of survival after receiving chemotherapy. In advanced or recurrent endometrial cancer, the Gynecologic Oncology Group (GOG) has used chemotherapy with the drugs cisplatin, doxorubicin and paclitaxel to treat these patients. Additionally, other doctors have used the drugs carboplatin and paclitaxel to treat similar patients. Both of these treatments have been shown to shrink tumors in patients with endometrial cancer. The purpose of this study is to find out whether treatment with the two-drug combination of carboplatin and paclitaxel is as good as the current standard three-drug combination of cisplatin, doxorubicin, and paclitaxel. Side effect information will also be analyzed to see if there are any differences between the two-drug and three-drug chemotherapy combinations with regard to ease of treatment and patient tolerance. Lastly, there are no known treatments for endometrial cancer that have been shown to be better than these two chemotherapy regimens.


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 PATIENT CHARACTERISTICS: AGE - 18 and over PERFORMANCE STATUS - GOG 0-2 LIFE EXPECTANCY - Not specified HEMATOPOIETIC - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 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 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 - Not specified OTHER - Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion


NCT ID:

NCT00698620


Primary Contact:

Study Chair
David S. Miller, MD
Simmons Cancer Center


Backup Contact:

N/A


Location Contact:

Newark, New Jersey 07101
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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