Clinical Pharmacology of Paclitaxel in Relation to Patient Age
55 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Stuart M. Lichtman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000065800
NCT ID:
NCT00003092
Start Date:
September 1997
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Mount Sinai Medical Center, NY | New York, New York 10029 |
| New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
