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A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer

Phase 2
16 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer


- Compare the efficacy of 2 different doses of ZD 1839, in terms of objective response,
PSA response, and duration of response, in patients with hormone-refractory
adenocarcinoma of the prostate.

- Compare the tolerability and quantitative toxicity of these regimens in these patients.

- Determine whether there is an association between any response or stable disease and
clinical benefit as assessed by changes in quality of life of patients treated with
these regimens.

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.

- Arm I: Patients receive oral, low-dose ZD 1839 twice daily on day 1 and once daily on
days 2-28 during course 1 and then once daily on days 1-28 during subsequent courses.

- Arm II: Patients receive oral, high-dose ZD 1839 as in arm I. Treatment in both arms
continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

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.

Inclusion Criteria


- 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

- 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



- 16 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- 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)


- Creatinine no greater than 2 times ULN


- 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


Biologic therapy:

- Concurrent epoetin alfa allowed


- 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


- At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive
radiotherapy approved by the National Cancer Institute of Canada, Clinical Trials


- See Disease Characteristics

- No concurrent ophthalmic surgery


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Malcolm J. Moore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

September 2008

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms