Ovarian Cancer Clinical Trial

Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00004081

Recruitment Status:

Completed

Sponsor:

Beth Israel Deaconess Medical Center

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There is 1 Location for this study

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Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00004081

Recruitment Status:

Completed

Sponsor:


Beth Israel Deaconess Medical Center

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