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

Condition(s) targeted: Breast Cancer; Lung Cancer; Prostate Cancer

Intervention: docetaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Arti Hurria, MD, Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Official title: Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetics of docetaxel

Secondary outcome:

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

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.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2002
Last updated: January 15, 2013