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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00025116 |
Purpose
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more effective in treating prostate cancer that has not responded to hormone therapy.
PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients who have prostate cancer that has not responded to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: gefitinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer |
| Study Start Date: | April 2001 |
| Study Completion Date: | September 2008 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at the end of each course during study, and then at 4 weeks after study.
Patients with stable or responding disease are followed at 4 weeks and then every 3 months until disease progression. All other patients are followed at 4 weeks only.
PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have documented evidence of disease progression, defined by 1 of the following conditions:
Rising PSA documented after discontinuation of peripheral antiandrogens
Minimum evidence of progression is a 25% increase in PSA over the reference value, provided that the increase is at least 5 ng/mL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, Ontario | |
| Ontario Cancer Institute | |
| Toronto, Ontario, Canada, M4X 1K9 | |
| Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
More Information
| ClinicalTrials.gov Identifier: | NCT00025116 History of Changes |
| Other Study ID Numbers: | I140, CAN-NCIC-IND140, CDR0000068915 |
| Study First Received: | October 11, 2001 |
| Last Updated: | November 7, 2010 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hormones Gefitinib |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |