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Phase II Trial of OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

Phase II Trial of OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median survival

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Paul Hesketh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03060

NCT ID:

NCT00087412

Start Date:

September 2004

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Southwest Oncology GroupSan Antonio, Texas  78245