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

Phase 2

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00003160
• Lead Sponsor: Theradex

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1997-09
• Study First Submitted: 1999-11-01
• Status Verified: 2001-01
• Study First Submitted QC: 2004-05-26
• Study First Posted: 2004-05-27
• Last Update Submitted: 2011-04-19
• Last Update Posted: 2011-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (18)

Akron General Medical Center; 🇺🇸 Akron, Ohio, United States

Women and Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

Harrington Cancer Center; 🇺🇸 Amarillo, Texas, United States

Rockwood Clinic P.S.; 🇺🇸 Spokane, Washington, United States

Oncology Center at Providence Park; 🇺🇸 Mobile, Alabama, United States

Good Samaritan Medical Center; 🇺🇸 West Palm Beach, Florida, United States

Cleveland Clinic Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Creighton University Cancer Center; 🇺🇸 Omaha, Nebraska, United States

Cancer Center of Santa Barbara; 🇺🇸 Santa Barbara, California, United States

Women's Health Center at Albany Medical Center; 🇺🇸 Albany, New York, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Women's Cancer Center of Central PA, P.C.; 🇺🇸 Harrisburg, Pennsylvania, United States

Jersey Shore Cancer Center; 🇺🇸 Neptune, New Jersey, United States

Oncology/Hematology Care, Inc.; 🇺🇸 Cincinnati, Ohio, United States

Brookview Research, Inc.; 🇺🇸 Nashville, Tennessee, United States

Hematology Associates, Ltd.; 🇺🇸 Phoenix, Arizona, United States

Highlands Oncology Group, P.A.; 🇺🇸 Fayetteville, Arkansas, United States

Decatur Memorial Hospital Cancer Care Institute; 🇺🇸 Decatur, Illinois, United States