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Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

erlotinib hydrochloride

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, bronchoalveolar cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)
- Stage IIIB (malignant pleural or pericardial effusion) disease
- Stage IV disease
- Recurrent and/or medically inoperable disease
Measurable or evaluable indicator lesions
No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
Life expectancy ≥ 8 weeks
WBC ≥ 3,000/mm³
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.0 mg/dL
AST ≤ 2 times upper limit of normal
Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
No significant medical history or unstable medical condition, including any of the following:
- Unstable systemic disease
- Congestive heart failure
- Recent myocardial infarction
- Unstable angina
- Active infection
- Uncontrolled hypertension
No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
At least 3 weeks since prior chemotherapy
No more than 1 prior chemotherapy regimen for NSCLC
No prior systemic cytotoxic chemotherapy for other malignant diseases
No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab [Herceptin®], or gefitinib)
No concurrent radiotherapy or chemotherapy

Sites / Locations

Northwestern Memorial Hospital
Memorial Sloan-Kettering Cancer Center
Vanderbilt-Ingram Cancer Center
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Intervention

Arm Description

Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.

Outcomes

Primary Outcome Measures

Major objective response rate (complete response and partial response)

Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions

Secondary Outcome Measures

Worst grade toxicity

Number of patients with worst-grade toxicity at each of five grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death) following NCI Common Toxicity Criteria, v. 2. Drug is discontinued for disease progression, unacceptable toxicity, patient undergoes radiation or other chemotherapy, or withdraws from study

Quality of life as measured by the Lung Cancer Symptom Scale for patients

The Lung Cancer Symptom Scale for patients is a nine-item scale with 0 = lowest rating (least) to 100 = highest rating (worst) for the measurement of symptom burden for loss of appetite, fatigue, cough, dyspnea, hemoptysis, activity, quality of life, lung cancer symptoms, and pain.

Survival

Duration of time from date of study entry to death from any cause or to the last date the patient is known to be alive.

Full Information

NCT ID

NCT00416650

First Posted

December 27, 2006

Last Updated

April 2, 2013

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00416650

Brief Title

Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Official Title

Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.

Detailed Description

OBJECTIVES: Primary Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride. Secondary Assess the quality of life of patients treated with this regimen. Determine the duration of response and time to disease progression in patients treated with this regimen. Determine the median survival of patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

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

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, bronchoalveolar cell lung cancer, recurrent 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

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Therapeutic Intervention

Arm Type

Experimental

Arm Description

Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.

Intervention Type

Drug

Intervention Name(s)

erlotinib hydrochloride

Other Intervention Name(s)

Tarceva, OSI-774

Intervention Description

All patients will receive 150 mg orally daily

Primary Outcome Measure Information:

Title

Major objective response rate (complete response and partial response)

Description

Time Frame

At 4 weeks and then every 8 weeks

Secondary Outcome Measure Information:

Title

Worst grade toxicity

Description

Time Frame

weekly for 4 weeks, then every 8 weeks to discontinuation of drug

Title

Quality of life as measured by the Lung Cancer Symptom Scale for patients

Description

Time Frame

baseline, every week for 5 weeks, and then every 4 weeks

Title

Survival

Description

Duration of time from date of study entry to death from any cause or to the last date the patient is known to be alive.

Time Frame

from study entry to date of death or last date known alive

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC) Stage IIIB (malignant pleural or pericardial effusion) disease Stage IV disease Recurrent and/or medically inoperable disease Measurable or evaluable indicator lesions No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids) PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100% Life expectancy ≥ 8 weeks WBC ≥ 3,000/mm³ Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm³ Bilirubin ≤ 1.0 mg/dL AST ≤ 2 times upper limit of normal Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min Not pregnant or nursing Fertile patients must use effective contraception No significant medical history or unstable medical condition, including any of the following: Unstable systemic disease Congestive heart failure Recent myocardial infarction Unstable angina Active infection Uncontrolled hypertension No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 3 weeks since prior radiation therapy to a major bone marrow-containing area At least 3 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for NSCLC No prior systemic cytotoxic chemotherapy for other malignant diseases No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab [Herceptin®], or gefitinib) No concurrent radiotherapy or chemotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Pao, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

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