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

Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and Recurrent Endometrial Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006377

Enrollment

Unknown

Registered

2003-05-30

Start date

2000-06-30

Completion date

2003-01-31

Last updated

2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma

Brief summary

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.

Detailed 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.

Interventions

DRUGcarboplatin

DRUGdoxorubicin hydrochloride

DRUGpaclitaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026