Clinical trial NCT00215709: Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer
Official title: A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: elderly
Lead sponsor: Geriatric Oncology Consortium
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-22
Enrollment: 17
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The information obtained from this trial will help determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in this patient population. If the data from this phase I trial are encouraging, a phase II trial will be conducted to further assess the efficacy of this dosing schedule.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) of docetaxel on a bi-weekly schedule in the treatment of elderly men with hormonal refractory prostate cancer (HRPC).
Secondary outcomes:
measure: To determine the dose limiting toxicity effects and other toxic effects of this regimen
measure: To determine the activity of this regimen in terms of: Overall response rates; Pain scores and analgesic use; PSA response rates;
measure: To evaluate the feasibility of using a self-report geriatric assessment tool in this population
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Geriatric Oncology Consortium
name: William Ershler, MD
role: PRINCIPAL_INVESTIGATOR
References: