Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188617
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2005-09-12
Brief Title:
Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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 toxicitybaseline 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 115 29
Biochemistry creatinine electrolytes bilirubin alkaline phosphatase ASTALT protein Day 115 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
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 ie 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 toxicitybaseline 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 115 29
Biochemistry creatinine electrolytes bilirubin alkaline phosphatase ASTALT protein Day 115 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
Detailed Description:
Primary and Secondary Outcomes
Objectives
To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A 1B NSCLC
Enrollment
Treatment will be administered on an outpatient basis Patients may be identified by thoracic surgeons respirologists andor interventional chest radiologists for study participation upon clinical and radiographic assessment
Diagnostic biopsy Pretreatment Investigations
If patients have already had a core or FNA biopsy before referral this material will be sought from the original pathologist for review and inclusion in the study with appropriate consent sought If a patient does not have a biopsy upon presentation to the thoracic surgeon and consents to inclusion in the trial baseline non-invasive assessment will be carried out before a percutaneous biopsy will be mandated as part of entry into the study After non-invasive staging patients will be subject to biopsy In collaboration with pathology an immediate diagnosis will be made at the time of fine needle aspiration biopsy or bronchoscopy After a pathologic diagnosis of cancer is confirmed subjects will be invited to have additional biopsies will be performed to obtain material for correlative studies assuming no complications or technical difficulties have arisen These studies will be done in collaboration with thoracic interventional radiologists from Diagnostic Imaging who supervises the lung fine needle aspirates and biopsies
All patients will undergo pre-study assessments for symptoms performance status radiographic assessment and blood tests complete blood count electrolytes liver and renal function tests Assessment of response will occur after the 4-week treatment period Toxicity will be assessed continuously with patient assessment weekly on treatment repeat blood tests at 2 weeks and imaging of measurable disease at 4 weeks All subjects will be invited to have their initial diagnostic biopsy and subsequent surgical tumor specimen examined as part of the laboratory correlate component of the study Patients will be considered evaluable for pharmacodynamic assessment if they complete at least 21 of the planned 28 days of therapy
Once competed oral Gefitinib will be administered at a dose of 250 mg 1 pill daily for 28 days prior to the planned mediastinoscopy Patients may take the pill either with or without food and are encouraged to take the medication at approximately the same time each day If the patient forgets to take a dose they should take the last missed dose as soon as they remember as long as it is at least 12 hours before the next dose is due If patient vomits after taking the dose the dose may be retaken if the tablet is seen in the emesis The last dose of Gefitinib will be administered not less than 48 hours prior to mediastinoscopy or surgery
If the mediastinoscopy reveals the presence of Stage III disease the patients mediastinoscopy samples may still be analysed as part of the correlative study Patients will be followed for 90 days or as long as required after the last dose of Gefitinib to ensure resolution of any Gefitinib-related toxicities However these patients will be offered standard therapy for stage III disease off of study protocol for example a combination of chemotherapy radiation plus or minus surgical resection If these patients do proceed to thoracotomy post-chemotherapy andor radiotherapy their resection specimen will not be eligible for this correlative protocol
Duration of Therapy and Follow-up
As outlined above patients will be treated for 28 days before surgery and will also be followed for 90 days post-operatively after thoracotomy to ensure the recovery from surgery Accrual is estimated at 2 patients per month for 18 to 24 months based on accrual rates to other thoracic surgical studies at UHN Study duration is planned from August 2004 to June 2006
All patients will be followed in the current standard of care at University Health Network That is clinic visits with chest x-ray every 3 months for 2 years every 6 months in the third year and annually thereafter Recorded information will only include vital status and presence or absence of disease recurrence
Objectives
To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A 1B NSCLC
Enrollment
Treatment will be administered on an outpatient basis Patients may be identified by thoracic surgeons respirologists andor interventional chest radiologists for study participation upon clinical and radiographic assessment
Diagnostic biopsy Pretreatment Investigations
If patients have already had a core or FNA biopsy before referral this material will be sought from the original pathologist for review and inclusion in the study with appropriate consent sought If a patient does not have a biopsy upon presentation to the thoracic surgeon and consents to inclusion in the trial baseline non-invasive assessment will be carried out before a percutaneous biopsy will be mandated as part of entry into the study After non-invasive staging patients will be subject to biopsy In collaboration with pathology an immediate diagnosis will be made at the time of fine needle aspiration biopsy or bronchoscopy After a pathologic diagnosis of cancer is confirmed subjects will be invited to have additional biopsies will be performed to obtain material for correlative studies assuming no complications or technical difficulties have arisen These studies will be done in collaboration with thoracic interventional radiologists from Diagnostic Imaging who supervises the lung fine needle aspirates and biopsies
All patients will undergo pre-study assessments for symptoms performance status radiographic assessment and blood tests complete blood count electrolytes liver and renal function tests Assessment of response will occur after the 4-week treatment period Toxicity will be assessed continuously with patient assessment weekly on treatment repeat blood tests at 2 weeks and imaging of measurable disease at 4 weeks All subjects will be invited to have their initial diagnostic biopsy and subsequent surgical tumor specimen examined as part of the laboratory correlate component of the study Patients will be considered evaluable for pharmacodynamic assessment if they complete at least 21 of the planned 28 days of therapy
Once competed oral Gefitinib will be administered at a dose of 250 mg 1 pill daily for 28 days prior to the planned mediastinoscopy Patients may take the pill either with or without food and are encouraged to take the medication at approximately the same time each day If the patient forgets to take a dose they should take the last missed dose as soon as they remember as long as it is at least 12 hours before the next dose is due If patient vomits after taking the dose the dose may be retaken if the tablet is seen in the emesis The last dose of Gefitinib will be administered not less than 48 hours prior to mediastinoscopy or surgery
If the mediastinoscopy reveals the presence of Stage III disease the patients mediastinoscopy samples may still be analysed as part of the correlative study Patients will be followed for 90 days or as long as required after the last dose of Gefitinib to ensure resolution of any Gefitinib-related toxicities However these patients will be offered standard therapy for stage III disease off of study protocol for example a combination of chemotherapy radiation plus or minus surgical resection If these patients do proceed to thoracotomy post-chemotherapy andor radiotherapy their resection specimen will not be eligible for this correlative protocol
Duration of Therapy and Follow-up
As outlined above patients will be treated for 28 days before surgery and will also be followed for 90 days post-operatively after thoracotomy to ensure the recovery from surgery Accrual is estimated at 2 patients per month for 18 to 24 months based on accrual rates to other thoracic surgical studies at UHN Study duration is planned from August 2004 to June 2006
All patients will be followed in the current standard of care at University Health Network That is clinic visits with chest x-ray every 3 months for 2 years every 6 months in the third year and annually thereafter Recorded information will only include vital status and presence or absence of disease recurrence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ASTRA ZENECA study D7913L00038 | None | None | None |