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Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer


Phase 2
N/A
N/A
Not Enrolling
Both
Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer

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Trial Information

Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer


Inclusion Criteria:



- Either bronchioloalveolar cell carcinoma or a variant thereof after review

- Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or
recurrent/medically inoperable disease

- Measurable or evaluable indicator lesions

- No prior or one chemotherapy regimen for NSCLC

- Three weeks since last chemotherapy, and three weeks since prior radiation therapy to
a major bone-marrow containing area

- Karnofsky performance status > or = to 80% OR ECOG performance status ≤ or = to 1

- Life expectancy > or = to 8 weeks

- Adequate hematologic, renal and/or hepatic function: WBC > or = to 3,000/ul,
hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin <
or = to 1.0 mg/dl, AST < than or = to 2.5 X UNL, creatinine < or = to 1.5 mg/dl or
Clcr > or = to 55ml/min.

- Effective contraception

Exclusion Criteria:

- Prior exposure to OSI-774 or other treatments targeting the HER family axis
(e.g.-trastuzumab, ZD1839, C225, etc.)

- Two or more prior chemotherapy regimens

- Concurrent active cancer

- Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is
radiographically unstable, symptomatic and/or requiring escalating doses of
corticosteroids)

- Pregnant or lactating women

- Malignancies within the past 5 years except for adequately treated carcinoma of the
cervix or basal or squamous cell carcinomas of the skin

- Prior systemic cytotoxic chemotherapy for other malignant disease

- Significant medical history or unstable medical condition (unstable systemic disease:
congestive heart failure, recent MI, unstable angina, active infection, uncontrolled
hypertension).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate of OSI-774 in bronchioloalveolar carcinoma of the lung.

Outcome Time Frame:

53 weeks

Safety Issue:

Yes

Principal Investigator

Christopher Azzoli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

02-010

NCT ID:

NCT00590902

Start Date:

March 2002

Completion Date:

February 2013

Related Keywords:

  • Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer
  • non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021