Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215709
• Other study ID #: GOC GU-010
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2005
• Last updated: November 15, 2007
• Start date: July 2004
• Est. completion date: July 2007

Study information

• Verified date: November 2007
• Source: Geriatric Oncology Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Geriatric Oncology Consortium	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the dose limiting toxicity effects and other toxic effects of this regimen
Secondary	To determine the activity of this regimen in terms of: Overall response rates; Pain scores and analgesic use; PSA response rates;
Secondary	To evaluate the feasibility of using a self-report geriatric assessment tool in this population

External Links

•   Geriatric Oncology Consoritum website