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.

Condition	Treatment or Intervention	Phase
stage III endometrial cancer stage IV endometrial cancer recurrent endometrial cancer	Procedure: chemotherapy  Drug: carboplatin  Drug: doxorubicin  Drug: paclitaxel	Phase II

Further Study Details: 

OBJECTIVES: I. 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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--Patient Characteristics--

Age: Adult

Performance status: Karnofsky 70-100%

Life expectancy: At least 12 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm3
• Platelet count at least 100,000/mm3

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000068251; MSKCC-00073; NCI-G00-1860
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006377
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08