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

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ClinicalTrials.gov Identifier: NCT00006377
Recruitment Status : Completed
First Posted : May 30, 2003
Last Update Posted : June 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: carboplatin Drug: doxorubicin hydrochloride Drug: paclitaxel Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and Recurrent Endometrial Cancer
Study Start Date : June 2000
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00006377     History of Changes
Other Study ID Numbers: 00-073
CDR0000068251 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G00-1860
First Posted: May 30, 2003    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors