A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer
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
PROJECTED ACCRUAL: There will be 100 patients accrued into this study.
Primary Purpose: Treatment
Maurie Markman, MD
The Cleveland Clinic
United States: Federal Government
|Cleveland Clinic Cancer Center
|Cleveland, Ohio 44195
|Brookview Research, Inc.
|Nashville, Tennessee 37203
|Akron General Medical Center
|Akron, Ohio 44302
|Harrington Cancer Center
|Amarillo, Texas 79106
|Carolinas Medical Center
|Charlotte, North Carolina 28232-2861
|Creighton University Cancer Center
|Omaha, Nebraska 68131-2197
|Women and Infants Hospital of Rhode Island
|Providence, Rhode Island 02905
|Good Samaritan Medical Center
|West Palm Beach, Florida 33401
|Jersey Shore Cancer Center
|Neptune, New Jersey 07753
|Hematology Associates, Ltd.
|Phoenix, Arizona 85013
|Oncology Center at Providence Park
|Mobile, Alabama 36608
|Highlands Oncology Group, P.A.
|Fayetteville, Arkansas 72703
|Cancer Center of Santa Barbara
|Santa Barbara, California 93105
|Decatur Memorial Hospital Cancer Care Institute
|Decatur, Illinois 62526
|Women's Health Center at Albany Medical Center
|Albany, New York 12209
|Oncology/Hematology Care, Inc.
|Cincinnati, Ohio 45219
|Women's Cancer Center of Central PA, P.C.
|Harrisburg, Pennsylvania 17105-8700
|Rockwood Clinic P.S.
|Spokane, Washington 99202