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

Primary Purpose

Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OSI-774: erlotinib, TarcevaTM

About this trial

This is an interventional treatment trial for Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer focused on measuring non small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 - OSI-774

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00590902

First Posted

December 26, 2007

Last Updated

October 3, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

M.D. Anderson Cancer Center, Northwestern University, Vanderbilt-Ingram Cancer Center, Dana-Farber Cancer Institute, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00590902

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

M.D. Anderson Cancer Center, Northwestern University, Vanderbilt-Ingram Cancer Center, Dana-Farber Cancer Institute, Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer

Keywords

non small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 - OSI-774

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

OSI-774: erlotinib, TarcevaTM

Intervention Description

150 mg, 100 mg and 25 mg tablets

Primary Outcome Measure Information:

Title

Overall Objective Response of OSI-774

Description

Time Frame

53 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Azzoli, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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