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Paclitaxel in Treating Older Patients With Solid Tumors

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00003092
Collaborator
National Cancer Institute (NCI) (NIH)
120
Enrollment
32
Locations
1
Arm
105
Duration (Months)
3.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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 vs cohort 2:

patients 65 to 75 vs cohort 3: patients 75 and over).

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
Study Start Date :
Sep 1, 1997
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paclitaxel

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.

Drug: paclitaxel

Outcome Measures

Primary Outcome Measures

  1. Overall survival [Up to 5 years]

  2. Disease-free progression [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rebecca and John Moores UCSD Cancer Center La Jolla California United States 92093-0658
2 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
3 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
4 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
5 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
6 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
7 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242-1009
8 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
9 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
10 University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
11 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
12 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
13 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
14 University of Nebraska Medical Center Omaha Nebraska United States 68198-7680
15 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
16 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
17 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
18 CCOP - North Shore University Hospital Manhasset New York United States 11030
19 North Shore University Hospital Manhasset New York United States 11030
20 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
21 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021
22 Mount Sinai Medical Center, NY New York New York United States 10029
23 State University of New York - Upstate Medical University Syracuse New York United States 13210
24 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
25 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
26 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
27 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
28 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
29 Rhode Island Hospital Providence Rhode Island United States 02903
30 University of Tennessee Cancer Institute Memphis Tennessee United States 38103
31 Vermont Cancer Center Burlington Vermont United States 05401-3498
32 MBCCOP - Massey Cancer Center Richmond Virginia United States 23298-0037

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Stuart M. Lichtman, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003092
Other Study ID Numbers:
  • CALGB-9762
  • U10CA031946
  • CLB-9762
  • CDR0000065800
First Posted:
Jan 27, 2003
Last Update Posted:
Jul 14, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Paclitaxel

Study Results

No Results Posted as of Jul 14, 2016