Clinical trial NCT00590902: Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer
Official title: Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer
Keywords: non small cell lung cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Northwestern University
name: Vanderbilt-Ingram Cancer Center
name: Dana-Farber Cancer Institute
name: Genentech, Inc.
First posted: 2008-01-11
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer.

This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.


Eligibility criteria: 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).

Primary outcomes:
measure: Overall Objective Response of OSI-774
timeFrame: 53 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Azzoli, MD
role: PRINCIPAL_INVESTIGATOR
References: