LUNG CANCERPhase 2NCT00188617
Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC
A Phase 2 study testing GEFITINIB in people with LUNG CANCER, run by University Health Network, Toronto at 1 site in Canada.
Trial 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 (i.e., not in the main bronchus)* or 1B (T2N0M0 a tumor with any of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LUNG CANCER
- What is being tested?
- GEFITINIB
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read more
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
Read the 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 and/or 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 patient's 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 and/or 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.
- Conditions
- LUNG CANCER
- Being tested
- GEFITINIB
- Keywords
- LUNG CANCER, IRESSA, GEFITINIB, STAGE 1A & 1B, NEOADJUVANT, PHASE 2
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEFITINIBDrug
Also called IRESSA
250 mg once a day for 28 days before surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
· To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
Measured: before starting drug and after 28 days of treatment
Secondary outcomes (1)
· To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A & 1B NSCLC
Measured: at baseline, 2weeks into treatment at 4weeks and 30 days after stopping drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUNG CANCERStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Thomas Waddell, MD FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188617
- Sponsor's protocol ID
- UHN REB04-0420-C
- Other IDs
- ASTRA ZENECA study D7913L00038
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00188617
- Acronym / sponsor ID
- UHN REB04-0420-C
- Conditions
- LUNG CANCER
- Keywords
- LUNG CANCER, IRESSA, GEFITINIB, STAGE 1A & 1B, NEOADJUVANT, PHASE 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 and/or 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 patient's 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 and/or 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEFITINIBAlso: IRESSA250 mg once a day for 28 days before surgery | Drug | – |
Primary outcome
· To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
Time frame: before starting drug and after 28 days of treatment
1 secondary outcome
· 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Waddell, MD FRCSC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GEFITINIB in people with LUNG CANCER, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
· To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment (time frame: before starting drug and after 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.