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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006377
First received: October 4, 2000
Last updated: December 3, 2009
Last verified: December 2002
History of Changes
  Purpose

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 Intervention Phase
Endometrial Cancer
 Drug: carboplatin
Drug: doxorubicin hydrochloride
Drug: paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and Recurrent Endometrial Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006377

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00006377     History of Changes
Other Study ID Numbers: CDR0000068251, MSKCC-00073, NCI-G00-1860
Study First Received: October 4, 2000
Last Updated: December 3, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
 Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial
Doxorubicin
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 22, 2013