Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00512668 |
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by lowering the amount of androgens the body makes. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hormone therapy together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with hormone therapy in treating patients with relapsed prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: bicalutamide Drug: flutamide Drug: goserelin Drug: leuprolide acetate Drug: nilutamide Drug: temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase Ib Study of Limited Androgen Ablation and Two Dose Levels of Temsirolimus (NSC#683864) in Patients With Prostate Cancer Who Have a Biochemical Relapse After Prostatectomy and/or Radiotherapy |
Estimated Enrollment: | 24 |
Study Start Date: | September 2007 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive combined androgen ablation therapy comprising a luteinizing hormone-releasing hormone analogue (i.e., leuprolide acetate intramuscularly once monthly or goserelin subcutaneously every 3 months) and an oral anti-androgen drug (i.e., bicalutamide or nilutamide once daily or flutamide 3 times daily) on days 1-90.* Beginning on day 60 of hormonal therapy, patients receive temsirolimus IV over 30 minutes once weekly. Treatment with temsirolimus continues for up to 36 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients may receive no more than 3 months of hormonal therapy, including therapy initiated within 2 months of study entry.
After completion of study therapy, patients are followed at 30 days.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Biochemical relapse after local therapy (i.e., radical prostatectomy and/or definitive radiotherapy), as evidenced by rising serum PSA
PSA doubling time ≤ 12 months after local therapy, as determined by linear regression of all available PSA values within 6 months of initiation of androgen ablation
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Prior systemic treatment for prostate cancer
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Christopher Logothetis, MD | M.D. Anderson Cancer Center |
Investigator: | Eleni Efstathiou | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000559627, MDA-2007-0025 |
Study First Received: | August 6, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00512668 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the prostate recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Nilutamide Leuprolide Goserelin Bicalutamide |
Urogenital Neoplasms Flutamide Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents |