Brief Title
Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer
Official Title
Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and Recurrent Endometrial Cancer
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.
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 Phase
Phase 2
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
June 2000
Completion Date
January 2003
Primary Completion Date
January 2003
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Sabbatini, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00006377
Organization ID
00-073
Secondary IDs
CDR0000068251
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paul Sabbatini, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
June 2013