Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and 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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-073

NCT ID:

NCT00006377

Start Date:

June 2000

Completion Date:

January 2003

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021