Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

NCT ID: NCT00003160

Last Updated: 2011-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-09-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.

Detailed Description

OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients.

OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: There will be 100 patients accrued into this study.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Theradex

INDUSTRY

Sponsor Role: lead

Principal Investigators

Maurie Markman, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Oncology Center at Providence Park

Mobile, Alabama, United States

Hematology Associates, Ltd.

Phoenix, Arizona, United States

Highlands Oncology Group, P.A.

Fayetteville, Arkansas, United States

Cancer Center of Santa Barbara

Santa Barbara, California, United States

Good Samaritan Medical Center

West Palm Beach, Florida, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Creighton University Cancer Center

Omaha, Nebraska, United States

Jersey Shore Cancer Center

Neptune City, New Jersey, United States

Women's Health Center at Albany Medical Center

Albany, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Akron General Medical Center

Akron, Ohio, United States

Oncology/Hematology Care, Inc.

Cincinnati, Ohio, United States

Cleveland Clinic Cancer Center

Cleveland, Ohio, United States

Women's Cancer Center of Central PA, P.C.

Harrisburg, Pennsylvania, United States

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Brookview Research, Inc.

Nashville, Tennessee, United States

Harrington Cancer Center

Amarillo, Texas, United States

Rockwood Clinic P.S.

Spokane, Washington, United States

Countries

United States

Other Identifiers

THERADEX-B97-3250

Identifier Type: -

Identifier Source: secondary_id

BMS-TAX/MEN.03

Identifier Type: -

Identifier Source: secondary_id

NCI-V97-1366

Identifier Type: -

Identifier Source: secondary_id

CDR0000065955

Identifier Type: -

Identifier Source: org_study_id