Paclitaxel in Treating Older Patients With Solid Tumors

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: November 1, 1999
Last updated: July 6, 2015
Last verified: July 2015

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Pharmacology of Paclitaxel in Relation to Patient Age

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Disease-free progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 1997
Study Completion Date: June 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:


  • 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).


Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003092

  Show 32 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Stuart M. Lichtman, MD Don Monti Comprehensive Cancer Center at North Shore University Hospital
  More Information

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00003092     History of Changes
Other Study ID Numbers: CALGB-9762, U10CA031946, CLB-9762, CDR0000065800
Study First Received: November 1, 1999
Last Updated: July 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on October 06, 2015