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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:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00006377
First received: October 4, 2000
Last updated: June 17, 2013
Last verified: June 2013

October 4, 2000
June 17, 2013
June 2000
January 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006377 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Endometrial Cancer
  • Drug: carboplatin
  • Drug: doxorubicin hydrochloride
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2003
January 2003   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006377
00-073, CDR0000068251, NCI-G00-1860
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP