Clinical trial NCT00006377: Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer
Official title: Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and Recurrent Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Sabbatini, MD
role: STUDY_CHAIR
References: