Adenocarcinoma of the LungPhase 2NCT00087412
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adenocarcinoma of the Lung and Large Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer
- What is being tested?
- erlotinib hydrochloride 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
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2007
- 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 histologically or cytologically proven newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified) or recurrent disease after previous surgery and/or irradiation
- Patients with brain metastases are ineligible; all patients with neurological abnormalities on physical exam or symptoms must have a negative pretreatment CT or MRI scan of the brain within 28 days prior to registration
- Patients must have measurable disease documented by CT, MRI, X-ray, physical exam or nuclear exam within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration
- Patients must have a Zubrod performance status of 2
- Patients may have received prior radiation therapy provided that at least three weeks have elapsed since the completion of prior radiation therapy and patients have recovered from all associated toxicities; measurable disease must be present outside the previous radiation field or a new lesion must be present
- Patients may have received prior surgery provided that at least three weeks have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities; patients must have measurable residual disease present outside the area of surgical resection
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- Patients must not have received prior hormonal, systemic (chemotherapy) or biologic therapy for non-small cell lung cancer; patients must not have received prior therapy with EGFR inhibitors
- Patients must not be currently receiving or planning to receive concurrent hormonal, biologic or radiation therapy to measurable or non-measurable lesions except patients may receive concurrent palliative radiation therapy to small field non-measurable sites of disease (painful bony metastases) as long as there are other sites of measurable disease outside of the radiation treatment field
- ANC of >= 1,500/ul
- Platelet count of >= 100,000/ul
- Serum bilirubin =< the institutional upper limit of normal (IULN) AND must satisfy one of the following:
- Alkaline phosphatase =< IULN and liver enzymes (SGOT or SGPT) =< 2 x the IULN
- Alkaline phosphatase =< 4 x the IULN and liver enzymes (SGOT or SGPT) =< the IULN
- Serum creatinine =< 2 mg/dl
- Patients must not have gastrointestinal tract disease resulting in an inability to take enteral medication, malabsorption syndrome, a requirement for IV alimentation, had prior surgical procedures affecting absorption or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
- Patients must have completed the prestudy Medical Conditions Questionnaire
- Patients are not required to complete the Medical Conditions Questionnaire if they are unable to read and understand English
- Correlative science studies: institutions must have received IRB approval of S9925 (the Lung Cancer Specimen Repository); patients must be offered participation in S9925; with the patient's consent, blood, plasma and tissue will be submitted for testing via S9925; patients must be registered separately to S9925 in order for institutions to receive credit for specimen submission
- Patients must not have a significant history of cardiac disease, i.e., uncontrolled high blood pressure, unstable angina, congestive-heart failure, myocardial infraction within the last six months, or cardiac ventricular arrhythmias requiring medication
- Patients must be willing to provide prior smoking history
- No prior malignancy is allowed except for 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 5 years
- If day 14, 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
- In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
- Pregnant or nursing women may not participate in this trial; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- 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 OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Read the detailed description
PRIMARY OBJECTIVES:
- To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774.
II. To evaluate the objective tumor response rates (confirmed plus unconfirmed, complete and partial), in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774.
III. To investigate in a preliminary manner possible correlations of EGFR expression, mutations, and/or EGFR polymorphisms with response and/or survival.
IV. To investigate in a preliminary manner possible correlations of activated signal pathway molecules, including basal p27 expression levels with response and/or survival.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
- Conditions
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- erlotinib hydrochloride, laboratory biomarker analysis
- Medical subject headings
- Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median survival
Measured: Up to 3 years
Secondary outcomes (2)
Response rates (confirmed plus unconfirmed, complete plus partial)
Measured: Up to 3 years
Toxicity rates graded according to the NCI CTCAE version 3.0
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startSep 2004
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the LungStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul Hesketh, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087412
- Sponsor's protocol ID
- NCI-2012-03060
- Other IDs
- S0341, U10CA032102, CDR0000377245
- Status last verified
- Feb 2013
- First submitted
- 8 Jul 2004
- 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 OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
- ClinicalTrials.gov ID
- NCT00087412
- Acronym / sponsor ID
- NCI-2012-03060
- Conditions
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous 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
- 65 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Jul 2007 (actual)
- First posted
- 12 Jul 2004 (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.
This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed description
PRIMARY OBJECTIVES:
- To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774.
II. To evaluate the objective tumor response rates (confirmed plus unconfirmed, complete and partial), in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774.
III. To investigate in a preliminary manner possible correlations of EGFR expression, mutations, and/or EGFR polymorphisms with response and/or survival.
IV. To investigate in a preliminary manner possible correlations of activated signal pathway molecules, including basal p27 expression levels with response and/or survival.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: erlotinib hydrochloride, Other: laboratory biomarker analysisPatients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must have histologically or cytologically proven newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified) or recurrent disease after previous surgery and/or irradiation
- Patients with brain metastases are ineligible; all patients with neurological abnormalities on physical exam or symptoms must have a negative pretreatment CT or MRI scan of the brain within 28 days prior to registration
- Patients must have measurable disease documented by CT, MRI, X-ray, physical exam or nuclear exam within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration
- Patients must have a Zubrod performance status of 2
- Patients may have received prior radiation therapy provided that at least three weeks have elapsed since the completion of prior radiation therapy and patients have recovered from all associated toxicities; measurable disease must be present outside the previous radiation field or a new lesion must be present
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 |
|---|---|---|
| erlotinib hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Given orally | Drug | Treatment |
| laboratory biomarker analysisCorrelative studies | Other | Treatment |
Primary outcome
Median survival
Time frame: Up to 3 years
2 secondary outcomes
Response rates (confirmed plus unconfirmed, complete plus partial)
Time frame: Up to 3 years
Toxicity rates graded according to the NCI CTCAE version 3.0
Time frame: Up to 3 years
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.
Paul Hesketh 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 erlotinib hydrochloride and laboratory biomarker analysis in people with Adenocarcinoma of the Lung and Large 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 26 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?
Median survival (time frame: Up to 3 years). 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.