Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer

NCT ID: NCT00059943

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with metastatic breast, lung, or prostate cancer.

Detailed Description

OBJECTIVES:

• Determine the pharmacokinetics of docetaxel in older patients with metastatic breast, lung, or prostate cancer.
• Determine the response of patients treated with this drug.
• Determine the toxicity of this drug in these patients.
• Determine the short-term changes in functional status, in terms of activities of daily living, independent activities of daily living, and Karnofsky performance status, in patients treated with this drug.
• Correlate the number of comorbid conditions at baseline with declines in functional status in patients treated with this drug.

OUTLINE: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.

Conditions

Breast Cancer; Lung Cancer; Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven metastatic breast, lung, or prostate cancer
• Measurable disease
• No untreated CNS metastases
• No symptomatic CNS metastases requiring escalating doses of corticosteroids
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 65 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Hemoglobin at least 8.0 g/dL
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin normal
• SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) with alkaline phosphatase no greater than ULN OR
• Alkaline phosphatase no greater than 4 times ULN with SGOT and SGPT no greater than ULN

Renal

• Not specified

Cardiovascular

• No history of cardiac arrhythmia
• No congestive heart failure
• No myocardial infarction within the past 6 months

Other

• No prior severe hypersensitivity reaction to docetaxel or other drugs containing polysorbate 80
• No allergy to macrolide antibiotics
• No grade 2 or greater peripheral neuropathy
• No concurrent serious or uncontrolled infection
• Able to read, write, and converse in English

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Recovered from prior chemotherapy

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• Not specified

Other

• No concurrent CYP3A4-inducing or inhibiting medications or herbal remedies
• No concurrent grapefruit juice
• No concurrent ethanol

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Arti Hurria, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-01136

Identifier Type: -

Identifier Source: secondary_id

01-136

Identifier Type: -

Identifier Source: org_study_id