Bronchoalveolar Cell Lung CancerPhase 2NCT00029003
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing gefitinib and laboratory biomarker analysis in people with Bronchoalveolar Cell Lung Cancer and Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchoalveolar Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- What is being tested?
- gefitinib and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Dec 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a biopsy-proven, incompletely resected or unresectable bronchioloalveolar carcinoma, with pathology tissue available for central review and staining for EGFR and other molecular variables; fine needle aspirates, bronchial brushings or washings are not permitted for diagnosis; patients must have either selected stage IIIB due to cytology-confirmed malignant pleural effusion, or stage IV disease; tumors may be multi-focal or diffuse
- Patients must have evidence of disease by CT scan of the chest; the pre-study CT scan of the chest must include the liver and adrenal glands or be accompanied by an abdominal CT scan in which they are visualized; all x-rays/scans to assess measurable disease must have performed within 28 days prior to registration; all other required tests to assess non-measurable disease must have been performed within 42 days prior to registration
- The institution must plan to submit all pathology materials (i.e., H\&E stained slide from each block, plus 10 unstained slide from one block) within 30 days after registration
- All patients must have a Zubrod performance status of 0-2
- Patients must not have received prior treatment with biologic therapies that target EGFR; patients may not be currently receiving or planning to receive any other treatment directed at the BAC
- Prior biologic therapy, chemotherapy and radiotherapy are allowed, provided that at least four weeks have elapsed since last treatment with these modalities and the patient's disease has been assessed since completing previous treatment; disease must be present outside of areas of previous radiation therapy
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- Prior surgery is allowed, provided that the patient has had sufficient recovery time from surgery, as determined by the enrolling physician
- Patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation; patients must not have had prior surgical procedures affecting absorption
- Serum bilirubin =< 1.5 x the institutional upper limit of normal
- SGOT or SGPT =< 2.5 x the institutional upper limit of normal (IULN) (if liver metastases are present; SGOT/SGPT =< 5 IULN allowed)
- Alkaline phosphatase =< 2.5 x IULN (if bone metastases are present, alkaline phosphatase =< 5 x IULN is allowed); abnormalities in alkaline phosphatase levels should be appropriately followed to document the possibility of bone or hepatic metastases
- ANC >= 1,500/uL
- WBC >= 3,000/uL
- Platelet count >= 100,000/uL
- Institution must have receive IRB approval for S9925; patients must be offered participating in S9925 (the Lung Cancer Specimen Repository); optional submissions of buccal brushings for EGFR determination will be done via the Lung Cancer Specimen Repository; patients must be registered separately to S9925 to receive credit for buccal brushing submission
- Patient with known brain metastases are ineligible for this clinical trial; if there are any abnormal findings on neurological examination suspicious for brain metastases, a CT or MRI should be performed within 42 days prior to registration
- NOTE: a baseline slit lamp examination is NOT required; however, patients with eye symptoms (eye pain, tearing, redness, vision problems) should be evaluated by an ophthalmologist/optometrist prior to registration and the results documented on the S0126 Toxicity and Dosage Form
- Patient must not have corneal inflammation or infection
- Patients requiring agents that induce CYP3A4 are excluded from the study, due to the ability of these agents to significantly reduce plasma concentrations of ZD1839 potentially below the range likely to be biologically active if taken concurrently with ZD1839 at the dose employed in the study; at the present time, agents known to induce CYP3A4 include the antibiotics nafcillin and rifampin, the anticonvulsants carbamazepine, phenobarbital, and phenytoin, as well as St. John's wort
- Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
- No other prior malignancy is allowed except to the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
- Pregnant or nursing women are not eligible to participate in this trial; women/men of reproductive potential must have agreed to use an effective contraceptive method
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Chronic Oral ZD1839 (Iressa®) (NSC-715055) in Both Previously-Untreated and Previously-Treated Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839.
II. To assess the progression-free survival and overall survival in these groups of patients.
III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.
IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease.
- To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes.
VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival.
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
- Conditions
- Bronchoalveolar Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- gefitinib, laboratory biomarker analysis
- Medical subject headings
- Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
Also called Iressa, ZD 1839
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (gefitinib) | Experimental | Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: gefitinib; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: Up to 1 year
Secondary outcomes (4)
Progression-free survival
Measured: From the date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 2 years
Change in EGFR and EGFR variant III overexpression and their relationship with survival
Measured: From baseline to up to 1 year
Response via CAIA versus response by RECIST
Measured: At 16 weeks
Toxicity as assessed by CTCAE version 3.0
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2001
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoalveolar Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Howard West, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029003
- Sponsor's protocol ID
- NCI-2012-03073
- Other IDs
- S0126, U10CA032102, CDR0000069157
- Status last verified
- Feb 2013
- First submitted
- 4 Jan 2002
- Last updated
- 28 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Chronic Oral ZD1839 (Iressa®) (NSC-715055) in Both Previously-Untreated and Previously-Treated Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
- ClinicalTrials.gov ID
- NCT00029003
- Acronym / sponsor ID
- NCI-2012-03073
- Conditions
- Bronchoalveolar Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2001
- Primary completion
- Dec 2004 (actual)
- First posted
- 27 Jan 2003 (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.
Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer
Detailed description
PRIMARY OBJECTIVES:
- To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839.
II. To assess the progression-free survival and overall survival in these groups of patients.
III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.
IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease.
- To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes.
VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival.
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (gefitinib) | Experimental | Drug: gefitinib, Other: laboratory biomarker analysisPatients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- Patients must have a biopsy-proven, incompletely resected or unresectable bronchioloalveolar carcinoma, with pathology tissue available for central review and staining for EGFR and other molecular variables; fine needle aspirates, bronchial brushings or washings are not permitted for diagnosis; patients must have either selected stage IIIB due to cytology-confirmed malignant pleural effusion, or stage IV disease; tumors may be multi-focal or diffuse
- Patients must have evidence of disease by CT scan of the chest; the pre-study CT scan of the chest must include the liver and adrenal glands or be accompanied by an abdominal CT scan in which they are visualized; all x-rays/scans to assess measurable disease must have performed within 28 days prior to registration; all other required tests to assess non-measurable disease must have been performed within 42 days prior to registration
- The institution must plan to submit all pathology materials (i.e., H\&E stained slide from each block, plus 10 unstained slide from one block) within 30 days after registration
- All patients must have a Zubrod performance status of 0-2
- Patients must not have received prior treatment with biologic therapies that target EGFR; patients may not be currently receiving or planning to receive any other treatment directed at the BAC
Key exclusion criteria (0 listed)
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: Iressa, ZD 1839Given orally | Drug | Treatment (gefitinib) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (gefitinib) |
Primary outcome
Overall survival rate
Time frame: Up to 1 year
4 secondary outcomes
Progression-free survival
Time frame: From the date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 2 years
Change in EGFR and EGFR variant III overexpression and their relationship with survival
Time frame: From baseline to up to 1 year
Response via CAIA versus response by RECIST
Time frame: At 16 weeks
Toxicity as assessed by CTCAE version 3.0
Time frame: Up to 30 days after completion of study treatment
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 28 Feb 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.
Howard West principal investigator
SWOG Cancer Research Network
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 and laboratory biomarker analysis in people with Bronchoalveolar Cell Lung Cancer and Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 24 inclusion and 0 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 28 Feb 2013. 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 United States. 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?
Overall survival rate (time frame: Up to 1 year). 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 28 Feb 2013.