Paclitaxel in Treating Older Patients With Solid Tumors - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003092

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 III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Clinical Pharmacology of Paclitaxel in Relation to Patient Age

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

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

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

Show 32 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Stuart M. Lichtman, MD

Don Monti Comprehensive Cancer Center at North Shore University Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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.

Lichtman SM, Egorin M, Rosner G, et al.: Clinical pharmacology of paclitaxel in relation to patient age: CALGB 9762. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A732, 1999.

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

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009