Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: OSI-774: erlotinib, TarcevaTM

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 - OSI-774	Drug: OSI-774: erlotinib, TarcevaTM; 150 mg, 100 mg and 25 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Objective Response of OSI-774	(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.	53 weeks

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: M.D. Anderson Cancer Center; Northwestern University; Dana-Farber Cancer Institute; Genentech, Inc.; Vanderbilt-Ingram Cancer Center
• Investigators: Principal Investigator: Christopher Azzoli, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimated): January 11, 2008

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: non small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: 02-010