S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer

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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