NCT00059943

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3 years

First QC Date

May 6, 2003

Last Update Submit

January 15, 2013

Conditions

Breast CancerLung CancerProstate Cancer

Keywords

stage IV breast cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancerrecurrent breast cancerstage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of docetaxel

Secondary Outcomes (5)

  • 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

Interventions

docetaxelDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsProstatic NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Arti Hurria, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

September 1, 2002

Primary Completion

September 1, 2005

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)