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Clinical Pharmacology of Paclitaxel in Relation to Patient Age

Phase 3
55 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Clinical Pharmacology of Paclitaxel in Relation to Patient Age


- 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

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


- Histologically proven nonhematologic malignancy



- 55 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin less than 1.5 mg/dL

- SGOT less than 2.0 times upper limit of normal (ULN)


- Creatinine no greater than 1.5 times ULN


- No uncontrolled or severe cardiovascular disease


- 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


Biologic therapy:

- Not specified


- 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


- At least 4 weeks since prior radiation therapy


- Not specified

Type of Study:


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


United States: Federal Government

Study ID:




Start Date:

September 1997

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



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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