Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer
Completed · Phase 1
Conditions studied: Prostate Cancer
In brief
This pilot study is designed to determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone refractory prostate cancer.
Key facts
- Study ID
- NCT00215709
- Run by
- Geriatric Oncology Consortium
- People needed
- 17
- Starts
- 2004-07-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2007-11-19
Who can join
Age: 65 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- age ≥ 65 years;
- histologically confirmed adenocarcinoma of the prostate;
- metastatic disease;
- unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in PSA at least 1 week apart;
- patients must have serum testosterone levels < 50 ng/mL at time of study entry. For patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression;
- prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. No evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;
- chemotherapy naïve;
- full recovery from the effects of any prior surgery or radiation therapy. At least 4 weeks since any radiation therapy;
- ECOG performance status 0-2;
- adequate kidney, liver, and bone marrow functions;
- signed study-specific informed consent form.
You may not qualify if…
- Concurrent chemotherapy or immunotherapy;
- Patients who have received an investigational drug within 4 weeks of registration;
- Prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years;
- Serious medical or psychiatric illness which would prevent informed consent;
- Life expectancy < 3 months;
- Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled;
- Known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.
Where it is running
- Study site — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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