Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer

Memorial Sloan Kettering Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Endometrial Cancer

Interventions

carboplatinDRUG

doxorubicin hydrochlorideDRUG

paclitaxelDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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