Know Cancer

forgot password

A Phase II Study Evaluating the Efficacy of Iressa Plus Etoposide in Patients With Advanced Hormone Refractory Prostate Cancer

Phase 2
19 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase II Study Evaluating the Efficacy of Iressa Plus Etoposide in Patients With Advanced Hormone Refractory Prostate Cancer



- Determine the activity of gefitinib and etoposide, in terms of overall response rate,
in patients with hormone-refractory advanced prostate cancer previously treated with
docetaxel-based therapy.


- Determine the toxicity of this regimen in these patients.

- Determine whether related biomarkers can help predict response in patients treated with
this regimen.

OUTLINE: This is a nonrandomized study.

Patients receive oral gefitinib once daily on days 1-28 and oral etoposide once daily on
days 1-14. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for
correlative studies. Blood samples are analyzed by enzyme-linked immunosorbent assays for
biomarkers (e.g., VEGF, basic fibroblast growth factor, and anti-EGFR antibody titers) in
order to determine whether one or more of these biomarkers can predict response.

After completion of study therapy, patients are followed periodically.

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 underwent prior surgical castration OR currently be on a luteinizing
hormone-releasing hormone agonist


- ANC > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 10 g/dL (in the absence of packed red blood cell transfusions within the
past 4 weeks)

- Creatinine < 2 mg/dL

- AST and ALT < 2 times upper limit of normal (ULN)

- Alkaline phosphatase < 2 times ULN

- Fertile patients must use effective double-method contraception during and for 1
month after completion of study treatment

- No other malignancy within the past 5 years except basal cell carcinoma

- No clinically significant New York Heart Association class II-IV cardiovascular

- 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

- No evidence of clinically active interstitial lung disease

- Patients with chronic, stable radiographic changes who are asymptomatic are


- See Disease Characteristics

- At 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

- The irradiated lesion must not be used to assess response rate

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate as measured by RECIST criteria

Outcome Description:

If there is at least 1 response, then 7 additional patients will be enrolled. If there are 4 or more responders overall, then the combination will be considered active and warrant further study.

Outcome Time Frame:

After 14 patients are enrolled

Safety Issue:


Principal Investigator

Ralph Hauke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680