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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Older Patients With Solid Tumors  Paclitaxel in Treating Older Patients With Solid Tumors
Paclitaxel in Treating Older Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.
Details: OBJECTIVES: - Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging. - Determine whether there is a relationship between the toxic effects of paclitaxel and aging. OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 (closed to accrual 6/23/2000) vs cohort 2: patients 65 to 74 (closed to accrual 9/29/2000) vs cohort 3: patients 75 and over). Patients receive a single dose of IV paclitaxel over 3 hours. Additional cycles of paclitaxel will be given at the discretion of the physician. Patients are followed for second malignancies, disease progression, and survival. PROJECTED ACCRUAL: A total of 120 patients (40 patients per cohort) will be accrued for this study within 2 or 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 55 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven nonhematologic malignancy PATIENT CHARACTERISTICS: Age: - 55 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 1.5 mg/dL - SGOT less than 2.0 times upper limit of normal (ULN) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled or severe cardiovascular disease Other: - No serious intercurrent medical illnesses that in the judgement of the investigator compromise patient care - No psychiatric conditions that would preclude study - No requirement for antibiotics for active acute infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No more than one prior chemotherapy regimen allowed - No prior paclitaxel allowed Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiation therapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StuartLichtman, Study Chair, North Shore University Hospital
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Additional Information:
Study ID Numbers: CDR0000065800; CLB-9762
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003092
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
2. E7389 in Treating Patients With Advanced Solid Tumors
3. Buspirone in Reducing Shortness of Breath in Patients With Cancer
4. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
5. S-3304 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Massachusetts Clinical Trials
Other Worcester Clinical Trials
Paclitaxel in Treating Older Patients With Solid Tumors
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