Clinical trial · Interventional
Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
NCT00059943CI-TRIAL-00008920completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pharmacokinetics of docetaxel
Secondary outcomes (5)
- measure
- Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
- measure
- Response
- measure
- Toxicity
- measure
- Correlation between toxicity and functional status decline
- measure
- Relationship between comorbid conditions at baseline and declines in functional status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.