Intervention: Gefitinib
Trial phase: Phase 2
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial.

Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).

Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Progressive disease after a prior docetaxel-based regimen OR failed a prior docetaxel-based regimen
Hormone-refractory disease, meeting 1 of the following criteria:
Radiologically measurable disease
Prostate-specific antigen (PSA) progression* while on hormonal therapy (including withdrawal from a direct antagonist) NOTE: *If the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA is required to document progression
Must have undergone prior surgical castration OR currently be on a luteinizing hormone-releasing hormone agonistANC > 1,500/mm³Platelet count > 100,000/mm³Hemoglobin > 10 g/dL (in the absence of packed red blood cell transfusions within the past 4 weeks)Creatinine < 2 mg/dLAST and ALT < 2 times upper limit of normal (ULN)Alkaline phosphatase < 2 times ULNFertile patients must use effective double-method contraception during and for 1 month after completion of study treatmentAt least 4 weeks since prior cytotoxic therapy
At least 4 weeks since prior direct antagonists, including flutamide and nilutamide
At least 6 weeks since prior bicalutamide
At least 30 days since prior nonapproved or investigational drugs
More than 4 weeks since prior palliative radiotherapy o The irradiated lesion must not be used to assess response rate

Exclusion Criteria:

No other malignancy within the past 5 years except basal cell carcinoma
No clinically significant New York Heart Association class II-IV cardiovascular disease
No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
No unresolved chronic toxicity > grade 2 from prior anticancer therapy, with the exception of alopecia
No other significant clinical disorder or laboratory finding that would preclude study participation
No known severe hypersensitivity to gefitinib or any of the excipients of this product

No evidence of clinically active interstitial lung disease

o Asymptomatic Patients with chronic, stable radiographic changes are eligible

No prior gefitinib or etoposide
No concurrent palliative radiotherapy
No concurrent chemotherapeutic agents
No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)
No concurrent hormones except antiandrogen therapy, steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
No concurrent initiation of IV and/or oral bisphosphonates specifically for symptomatic bone metastases