Overview
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Status:
Completed
Completed
Trial end date:
2008-09-22
2008-09-22
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
NCIC Clinical Trials GroupTreatments:
Gefitinib
Hormones
Criteria
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 allowed