Non-small Cell Lung CancerPhase 1/2NCT00268255
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
A Phase 1/2 study testing gefitinib, adjuvant therapy and enzyme inhibitor therapy in people with Non-small Cell Lung Cancer, run by Barbara Ann Karmanos Cancer Institute.
Trial summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- gefitinib, adjuvant therapy and enzyme inhibitor therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Any non-small cell histology allowed
- T1-3, N0* disease
- No metastatic disease
- Refused or ineligible for surgery
- Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: *No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance
PATIENT CHARACTERISTICS:
Performance status
- Any performance status
Life expectancy
- At least 1 year
Hematopoietic
- No restrictions
Hepatic
- No restrictions
Renal
- Creatinine ≤ CTC grade 2
Pulmonary
- No clinically active interstitial lung disease
- Chronic, stable, asymptomatic radiographic changes allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No known severe hypersensitivity to gefitinib or any of the excipients of this product
- No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix
- No active or uncontrolled infection
- No uncontrolled systemic disease
- No psychiatric illness or other severe medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy
Radiotherapy
- No prior radiotherapy to the chest or mediastinum
- No concurrent elective nodal irradiation
Surgery
- Recovered from prior surgery
- No concurrent ophthalmic surgery
Other
- Recovered from all other prior anticancer therapy (alopecia allowed)
- More than 30 days since prior nonapproved or investigational agents
- No concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- No concurrent systemic retinoids
About this study
Official title: Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the toxicity profile and maximum tolerated dose of radiotherapy when given in combination with gefitinib in patients with previously untreated, medically inoperable stage I or II non-small cell lung cancer. (Phase I)
- Determine the efficacy of gefitinib when given for 6 weeks prior to and concurrent with radiotherapy, in terms of objective response rate (partial and complete response), in these patients.
Secondary
- Determine the 3-month tumor response (complete and partial response) in patients treated with this regimen.
- Determine the 6-week response rate in patients treated with this regimen.
- Determine the local disease control rate (complete and partial response, stable disease) in patients treated with this regimen.
- Determine the local progression-free survival and disease-specific survival (cancer vs co-morbid disease) of patients treated with this regimen.
- Determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
- Determine the acute and late radiation toxic effects to organs at risk in patients treated with this regimen.
- Determine the safety profile of gefitinib in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of radiotherapy.
- Patients receive oral gefitinib once daily for 13 weeks. Patients also undergo radiotherapy 5 days a week for 7 weeks beginning at week 7. Patients continue to receive gefitinib alone after completion of radiotherapy in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience acute dose-limiting toxicity.
- Phase II: Patients receive oral gefitinib as in phase I and radiotherapy at the MTD determined in phase I. After the completion of radiotherapy, patients continue to receive gefitinib in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- gefitinib, adjuvant therapy, enzyme inhibitor therapy, neoadjuvant therapy, protein tyrosine kinase inhibitor therapy
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, adenocarcinoma of the lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Bronchiolo-Alveolar, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
adjuvant therapyProcedure or surgery
enzyme inhibitor therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
protein tyrosine kinase inhibitor therapyProcedure or surgery
radiation therapyProcedure or surgery
radiosensitizationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
Why it stopped: Study never moved forward with accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Andrew T. Turrisi, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268255
- Sponsor's protocol ID
- CDR0000447160
- Other IDs
- WSU-D-2820, WSU-HIC-100304M1F, ZENECA-1839US/0258
- Status last verified
- Apr 2013
- First submitted
- 20 Dec 2005
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00268255
- Acronym / sponsor ID
- CDR0000447160
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, adenocarcinoma of the lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never moved forward with accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca
- First posted
- 22 Dec 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.
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the toxicity profile and maximum tolerated dose of radiotherapy when given in combination with gefitinib in patients with previously untreated, medically inoperable stage I or II non-small cell lung cancer. (Phase I)
- Determine the efficacy of gefitinib when given for 6 weeks prior to and concurrent with radiotherapy, in terms of objective response rate (partial and complete response), in these patients.
Secondary
- Determine the 3-month tumor response (complete and partial response) in patients treated with this regimen.
- Determine the 6-week response rate in patients treated with this regimen.
- Determine the local disease control rate (complete and partial response, stable disease) in patients treated with this regimen.
- Determine the local progression-free survival and disease-specific survival (cancer vs co-morbid disease) of patients treated with this regimen.
- Determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
- Determine the acute and late radiation toxic effects to organs at risk in patients treated with this regimen.
- Determine the safety profile of gefitinib in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of radiotherapy.
- Patients receive oral gefitinib once daily for 13 weeks. Patients also undergo radiotherapy 5 days a week for 7 weeks beginning at week 7. Patients continue to receive gefitinib alone after completion of radiotherapy in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience acute dose-limiting toxicity.
- Phase II: Patients receive oral gefitinib as in phase I and radiotherapy at the MTD determined in phase I. After the completion of radiotherapy, patients continue to receive gefitinib in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
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
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 |
|---|---|---|
| gefitinib | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| enzyme inhibitor therapy | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| protein tyrosine kinase inhibitor therapy | Procedure or surgery | – |
| radiation therapy | Procedure or surgery | – |
| radiosensitization | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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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.
Andrew T. Turrisi, MD study chair
Barbara Ann Karmanos Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gefitinib, adjuvant therapy and enzyme inhibitor therapy in people with Non-small Cell Lung Cancer, run by Barbara Ann Karmanos Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 16 Apr 2013.