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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416650
• Other study ID #: VCC THO 0214
• Secondary ID: P50CA090949P30CA
• Status: Completed
• Phase: Phase 2
• First received: December 27, 2006
• Last updated: April 2, 2013
• Start date: July 2002
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• erlotinib hydrochloride
All patients will receive 150 mg orally daily

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 4 weeks and then every 8 weeks	No
Secondary	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	weekly for 4 weeks, then every 8 weeks to discontinuation of drug	Yes
Secondary	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.	baseline, every week for 5 weeks, and then every 4 weeks	No
Secondary	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.	from study entry to date of death or last date known alive	No