Clinical trial · Interventional
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
NCT00025116CI-TRIAL-00044488completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* PSA at least 20 ng/mL at study entry
* 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
* Must have a first increase in PSA documented at least 1 week after the reference value and a second increase in PSA documented at least 1 week after the first increase
* Progressive measurable disease during androgen ablative therapy (including medical or surgical castration)
* Castrate level (no greater than 50 ng/mL) of testosterone required if receiving medical androgen-ablative therapy at study entry
* Concurrent luteinizing hormone-releasing hormone agonist therapy required if receiving this medication at study entry
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases)
Renal:
* Creatinine no greater than 2 times ULN
Other:
* No other malignancy within the past 5 years
* No active uncontrolled bacterial, fungal, or viral infection
* No significant neurological disorder that would preclude informed consent
* No other serious illness or medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Concurrent epoetin alfa allowed
Chemotherapy:
* No prior chemotherapy
* No concurrent cytotoxic therapy
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior peripheral antiandrogens (6 weeks for bicalutamide)
* Concurrent steroids allowed if on stable dose for at least 4 weeks before study and no dose increase planned
Radiotherapy:
* At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy approved by the National Cancer Institute of Canada, Clinical Trials Group
Surgery:
* See Disease Characteristics
* No concurrent ophthalmic surgery
Other:
* No prior investigational agents
* No other concurrent investigational therapy
* No concurrent ketoconazole
* No concurrent high-dose narcotic therapy for pain (e.g., morphine equivalent dose more than 60 mg/day)
* Concurrent bisphosphonates allowedReferences
Publications (1)
- RESULTCanil CM, Moore MJ, Winquist E, Baetz T, Pollak M, Chi KN, Berry S, Ernst DS, Douglas L, Brundage M, Fisher B, McKenna A, Seymour L. Randomized phase II study of two doses of gefitinib in hormone-refractory prostate cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group. J Clin Oncol. 2005 Jan 20;23(3):455-60. doi: 10.1200/JCO.2005.02.129. PMID 15659491