We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paclitaxel in Treating Older Patients With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003092
First Posted: January 27, 2003
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  Purpose

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: None (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 ]
  • Disease-free progression [ Time Frame: Up to 5 years ]

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:

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003092


  Show 32 Study Locations
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
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003092     History of Changes
Other Study ID Numbers: CALGB-9762
U10CA031946 ( U.S. NIH Grant/Contract )
CLB-9762
CDR0000065800 ( Registry Identifier: NCI Physician Data Query )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: July 14, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


To Top