Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	65 and over	NCI	MSKCC-01136 NCT00059943

Objectives

1. Determine the pharmacokinetics of docetaxel in older patients with metastatic breast, lung, or prostate cancer.
2. Determine the response of patients treated with this drug.
3. Determine the toxicity of this drug in these patients.
4. 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.
5. Correlate the number of comorbid conditions at baseline with declines in functional status in patients treated with this drug.

Entry 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

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

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/mm³
• Hemoglobin at least 8.0 g/dL
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Pharmacokinetics of docetaxel

Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
Response
Toxicity
Correlation between toxicity and functional status decline
Relationship between comorbid conditions at baseline and declines in functional status

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Arti Hurria, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-8895; 800-525-2225

Registry Information
Official Title		Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older with Metastatic Breast or Lung Cancer
Trial Start Date		2002-09-06
Registered in ClinicalTrials.gov		NCT00059943
Date Submitted to PDQ		2003-03-12
Information Last Verified		2005-08-18
NCI Grant/Contract Number		P30-CA08748

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