ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00025116 | Completed Phase 2 DMC

• 3 other identifiers: I140CAN-NCIC-IND140CDR0000068915
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Interventions

gefitinib DRUG

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (2)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Ontario Cancer Institute

Toronto, Ontario, M4X 1K9, Canada

Location

Related Publications (1)

• Canil 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 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Malcolm J. Moore, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: September 17, 2003
• Study Start: April 24, 2001
• Primary Completion: June 5, 2003
• Study Completion: September 22, 2008
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)