Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

Official title:

A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004081
• Other study ID #: CDR0000067292
• Secondary ID: BIH-99-1286NCI-V
• Status: Completed
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: August 9, 2012
• Start date: July 1999
• Est. completion date: March 2003

Study information

• Verified date: August 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2003
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 c — View Citation