Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
RATIONALE: Biological therapies such as gefitinib may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether gefitinib is effective in delaying the recurrence of non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in treating patients who have undergone surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (Iressa) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer|
- Overall survival [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]The 3-year survival for the 60% of patients with stage IB and II together is about 63% for those who did not receive post-operative chemotherapy, and is 67% for those who had received post-operative chemotherapy. Assuming 75% of patients may receive post-operative chemotherapy, the corresponding median survival for this subgroup of patients is about 64 months (5.3 years)
- Disease free survival [ Time Frame: approxmately 3 years ] [ Designated as safety issue: No ]
- Prognostic significance of EGFR expression [ Time Frame: approxmately 3 years ] [ Designated as safety issue: No ]
- Toxicity of ZD1839 [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]Adverse events will be monitored on an ongoing basis by the central office and presented every 6 months in an unblinded fashion to the Data Safety Monitoring Committee of the NCIC CTG.
|Study Start Date:||September 2002|
|Study Completion Date:||January 2012|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: IRESSA (ZD1839)||
Drug: IRESSA (ZD1839)
250mg daily oral dose for 2 years
|Placebo Comparator: Placebo||
Other: Placebo comparator
daily oral dose of 250mg tablet for 2yrs (matching placebo comparator)
- Compare the overall survival of patients with completely resected primary stage IB, II, or IIIA non-small cell lung cancer treated with gefitinib vs placebo.
- Compare the disease-free survival of patients treated with these regimens.
- Determine the prognostic significance of epidermal growth factor receptor expression, phosphorylation, and mutations in the primary tumor in predicting relative impact of gefitinib on survival of these patients.
- Establish a comprehensive tumor bank linked to a clinical database for further study of molecular markers in patients treated with these regimens.
- Determine the toxicity of gefitinib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (IB vs II vs IIIA), histological subtype (squamous cell vs others), postoperative radiotherapy (yes vs no), prior adjuvant platinum-based chemotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral gefitinib daily, unless otherwise directed by the investigator.
- Arm II: Patients receive oral placebo daily, unless otherwise directed by the investigator.
Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, 3 months, and every 3 months for 30 months after randomization, then every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,242 patients (621 per treatment arm) will be accrued for this study within 3.5 years.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|BCCA - Vancouver Island Cancer Centre|
|Victoria, British Columbia, Canada, V8R 6V5|
|Canada, New Brunswick|
|Atlantic Health Sciences Corporation|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Newfoundland and Labrador|
|Dr. H. Bliss Murphy Cancer Centre|
|St. John's, Newfoundland and Labrador, Canada, AIB 3V6|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Lakeridge Health Oshawa|
|Oshawa, Ontario, Canada, L1G 2B9|
|Ottawa Health Research Institute - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Algoma District Cancer Program|
|Sault Ste. Marie, Ontario, Canada, P6B 0A8|
|Niagara Health System|
|St. Catharines, Ontario, Canada, L2R 7C6|
|Regional Cancer Program of the Hopital Regional|
|Sudbury, Ontario, Canada, P3E 5J1|
|Thunder Bay Regional Health Science Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Joseph's Health Centre|
|Toronto, Ontario, Canada, M6R 1B5|
|Trillium Health Centre - West Toronto|
|Toronto, Ontario, Canada, M9C 1A5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada, N8W 2X3|
|Canada, Prince Edward Island|
|PEI Cancer Treatment Centre,Queen Elizabeth Hospital|
|Charlottetown, Prince Edward Island, Canada, C1A 8T5|
|Hopital Charles LeMoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|L'Hotel-Dieu de Levis|
|Levis, Quebec, Canada, G6V 3Z1|
|Hopital du Sacre-Coeur de Montreal|
|Montreal, Quebec, Canada, H4J 1C5|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|University Institute of Cardiology and|
|Quebec, Canada, G1V 4G5|
|Study Chair:||Glenwood D. Goss, MD, BCh, FCP, FRCPC||Ottawa Regional Cancer Centre|
|Study Chair:||Gregory A. Masters, MD||Robert H. Lurie Cancer Center|
|Study Chair:||Peter F. Roberts, MD||University of California, Davis|