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

NCT00215709 | Completed Phase 1

• 1 other identifier: GOC GU-010
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

elderly

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• To determine the dose limiting toxicity effects and other toxic effects of this regimen

• To determine the activity of this regimen in terms of: Overall response rates; Pain scores and analgesic use; PSA response rates;

• To evaluate the feasibility of using a self-report geriatric assessment tool in this population

Interventions

docetaxel DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Geriatric Oncology Consortium: lead
• Sanofi: collaborator

Study Sites (1)

Unknown Facility

Baltimore, Maryland, 21211, United States

Location

Related Links

• Geriatric Oncology Consoritum website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• William Ershler, MD

  Geriatric Oncology Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2004
• Study Completion: July 1, 2007
• Last Updated: November 19, 2007

Record last verified: 2007-11

Locations

US (1)