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Clinical Pharmacology of Paclitaxel in Relation to Patient Age


Phase 3
55 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
University of Tennessee Cancer InstituteMemphis, Tennessee  38103