Brief Title
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
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
Brief 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
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Median survival
Secondary Outcome
Response rates (confirmed plus unconfirmed, complete plus partial)
Condition
Adenocarcinoma of the Lung
Intervention
erlotinib hydrochloride
Study Arms / Comparison Groups
Treatment
Description: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
September 2004
Primary Completion Date
July 2007
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Hesketh, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00087412
Organization ID
NCI-2012-03060
Secondary IDs
S0341
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Paul Hesketh, Principal Investigator, Southwest Oncology Group
Verification Date
February 2013