Paclitaxel in Treating Older Patients With Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003092
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: May 2003
  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: 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 National Cancer Institute (NCI):

Study Start Date: September 1997
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 (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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003092

  Show 32 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Stuart M. Lichtman, MD Don Monti Comprehensive Cancer Center at North Shore University Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003092     History of Changes
Other Study ID Numbers: CDR0000065800, CLB-9762
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014