Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin, paclitaxel, and carboplatin in treating patients who have primary stage III, stage IV, or recurrent endometrial cancer.


Study summary:

OBJECTIVES: - Determine the response rate and duration of response in patients with primary stage III or IV or recurrent endometrial cancer treated with sequential doxorubicin, paclitaxel, and carboplatin. OUTLINE: Patients receive sequential chemotherapy comprised of doxorubicin IV once every 2 weeks for 3 courses, followed by paclitaxel IV over 1 hour once weekly for 9 courses, and then carboplatin IV once every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven primary stage III or IV or recurrent endometrial cancer - Bidimensionally measurable disease by x-ray, CT scan, MRI scan, or physical exam - Sole site may be within a previously irradiated area if documented disease progression since prior radiotherapy PATIENT CHARACTERISTICS: Age: - Adult Performance status: - Karnofsky 70-100% Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin, SGOT, and alkaline phosphatase no greater than 1.5 times normal Renal: - Creatinine no greater than 1.8 mg/dL Cardiovascular: - Left ventricular ejection fraction at least 50% Other: - No active uncontrolled infection - No greater than grade II neuropathy - No other active malignancy - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior doxorubicin - Greater than 6 months since prior paclitaxel, carboplatin, or other platinum compounds Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified


NCT ID:

NCT00006377


Primary Contact:

Study Chair
Paul Sabbatini, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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