Paclitaxel in Treating Older Patients With Solid Tumors - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^ICMJE

September 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Paclitaxel in Treating Older Patients With Solid Tumors

Official Title ^ICMJE

Clinical Pharmacology of Paclitaxel in Relation to Patient Age

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

Lichtman SM, Hollis D, Miller AA, Rosner GL, Rhoades CA, Lester EP, Millard F, Byrd J, Cullinan SA, Rosen DM, Parise RA, Ratain MJ, Egorin MJ; Cancer and Leukemia Group B (CALGB 9762). Prospective evaluation of the relationship of patient age and paclitaxel clinical pharmacology: Cancer and Leukemia Group B (CALGB 9762). J Clin Oncol. 2006 Apr 20;24(12):1846-51. Epub 2006 Mar 27.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003092

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065800, CLB-9762

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Stuart M. Lichtman, MD

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP