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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: doxorubicin hydrochloride; Drug: carboplatin; Drug: paclitaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006377

NCI-G00-1860

CDR0000068251 (Registry Identifier)

00-073

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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