Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer
NCT ID: NCT00006377
Last Updated: 2013-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2000-06-30
2003-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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carboplatin
doxorubicin hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Paul Sabbatini, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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00-073
Identifier Type: -
Identifier Source: org_study_id
CDR0000068251
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-G00-1860
Identifier Type: -
Identifier Source: secondary_id
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