Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188617
First received: September 12, 2005
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

ELIGIBILITY

  • Non-small cell lung cancer Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)* or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung).
  • Must be deemed appropriate surgical candidate
  • ECOG performance status £ 2
  • Age ³ 18 years
  • No prior chemotherapy, radiotherapy or EGFR inhibitors

PRE-TREATMENT INVESTIGATIONS

  • History, physical examination, hematology, biochemistry, toxicity/baseline symptoms: within 7 days of registration
  • Radiology: CT chest within 7 days of registration
  • Tumor biopsy prior to treatment

TREATMENT

  • Gefitinib 250 mg will be administered orally daily x 28 days

EVALUATIONS ON TREATMENT

  • Physical examination (vital signs, weight, ECOG performance status) weekly x 4
  • Hematology (CBC, differential): Day 1,15, 29
  • Biochemistry (creatinine, electrolytes, bilirubin, alkaline phosphatase, AST/ALT, protein): Day 1,15, 29
  • Radiology: CT at baseline and after day 28
  • Toxicity evaluation: continuous

DURATION OF TREATMENT

  • Treatment is to be discontinued in cases of serious or unacceptable toxicity, or by patient or physician request
  • Otherwise duration of therapy will be a maximum of 28 days

Condition Intervention Phase
LUNG CANCER
Drug: GEFITINIB
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Single Agent Gefitinib (Iressa) In Patients With Clinical Stage I Non-Small Cell Lung Cancer (NSCLC) Proceeding To Mediastinoscopy And Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • · To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment [ Time Frame: before starting drug and after 28 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • · To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A & 1B NSCLC [ Time Frame: at baseline, 2weeks into treatment at 4weeks and 30 days after stopping drug ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: January 2005
Study Completion Date: November 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GEFITINIB
    250 mg once a day for 28 days before surgery
    Other Name: IRESSA
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have biopsy-proven non-small cell lung carcinoma (NSCLC) or a lung nodule seen on CT imaging and a high-clinical suspicion of NSCLC
  • Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)
  • or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung).

    • Must be deemed appropriate surgical candidate
    • ECOG performance status £ 2
    • Age ³ 18 years
    • No prior chemotherapy, radiotherapy or EGFR inhibitors
    • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have received prior anticancer treatment with chemotherapy, radiotherapy or EGFR inhibitor therapy;
  • Patients who have had a previous diagnosis of cancer, are excluded except if have been adequately treated for non-melanoma skin cancer or carcinoma in situ of the cervix are eligible irrespective of when that treatment was given.
  • Patients may not be receiving any other investigational or anticancer agents while on study;
  • History of allergic reactions to Gefitinib or erlotinib
  • Pre-existing diarrhea ³ NCI CTC Grade 2
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, poorly controlled diabetes mellitus, clinically significant or untreated ophthalmologic (e.g. Sjogrens etc.) or gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis) or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women because of the unknown effects of Gefitinib on the human fetus.
  • HIV-positive patients on active treatment
  • Active malignancy at any other site including combined small cell and non-small cell carcinomas or a pulmonary carcinoid tumor.
  • Taking drugs that induce CYP3A4 enzymes, patients with ongoing use of phenytoin, rifampicin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded.
  • Incomplete healing from previous surgery.
  • Use of any agent that decreases gastric pH, including proton pump inhibitors, Histamine-2 receptor blockers or sodium bicarbonate. Use of calcium or magnesium based elixirs are not included.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188617

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
AstraZeneca
Investigators
Principal Investigator: Thomas Waddell, MD FRCSC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Natasha Leighl & Thomas Waddell, University Health Network
ClinicalTrials.gov Identifier: NCT00188617     History of Changes
Other Study ID Numbers: UHN REB04-0420-C, ASTRA ZENECA study D7913L00038
Study First Received: September 12, 2005
Last Updated: December 5, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by University Health Network, Toronto:
LUNG CANCER
IRESSA
GEFITINIB
STAGE 1A & 1B
NEOADJUVANT
PHASE 2

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014