- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004081
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Stephen A. Cannistra, MD, Beth Israel Deaconess Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067292
- BIH-99-1286
- NCI-V99-1565
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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