Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
NCT ID: NCT00004081
Last Updated: 2012-08-13
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
30 participants
INTERVENTIONAL
1999-07-31
2003-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.
Detailed Description
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* Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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docetaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy
* Platinum resistance as defined by one of the following:
* Relapse within 6 months of platinum based chemotherapy
* Residual disease after completion of platinum based chemotherapy
* Disease progression while receiving platinum based chemotherapy
* Marker only relapse (CA-125 elevation) and measurable disease
* Bidimensionally measurable disease on exam or CT scan
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Performance status:
* ECOG 0-2
Life expectancy:
* Greater than 2 months
Hematopoietic:
* WBC at least 3,000/mm3
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGPT or SGOT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* Acceptable cardiac exam
* No active cardiac ischemia
Pulmonary:
* Acceptable pulmonary exam
* No active pulmonary infection or compromise
Other:
* Not pregnant or nursing
* No severe peripheral neuropathy (grade 2 or greater)
* No other significant psychiatric or medical conditions that would interfere with compliance
* No other malignancies within the past 3 years, except:
* Limited basal or squamous cell skin cancer
* Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior cytokine therapy
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer
* Prior paclitaxel allowed
* No prior docetaxel
* At least 3 years since prior chemotherapy for other disease
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior pelvic radiotherapy
Surgery:
* Not specified
18 Years
FEMALE
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Stephen Cannistra, MD
Investigator
Principal Investigators
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Stephen A. Cannistra, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Berkenblit A, Seiden MV, Matulonis UA, Penson RT, Krasner CN, Roche M, Mezzetti L, Atkinson T, Cannistra SA. A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer. Gynecol Oncol. 2004 Dec;95(3):624-31. doi: 10.1016/j.ygyno.2004.08.028.
Other Identifiers
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BIH-99-1286
Identifier Type: -
Identifier Source: secondary_id
NCI-V99-1565
Identifier Type: -
Identifier Source: secondary_id
CDR0000067292
Identifier Type: -
Identifier Source: org_study_id