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

NCT00416650 | Completed Phase 2 DMC

• 6 other identifiers: VCC THO 0214P50CA090949P30CA068485VU-VCC-THO-0214VU-VCC-IRB-02-0168GENENTECH-VU-VCC-THO-0214
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Worst grade toxicity

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

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

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

• Survival

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

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

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

Drug: erlotinib hydrochloride

Interventions

erlotinib hydrochloride DRUG

All patients will receive 150 mg orally daily

Also known as: Tarceva, OSI-774

Therapeutic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William Pao, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Cancer Biology, & Pathology/ Microbiology/ Immunology; Director, Division of Hematology and Oncology; Ingram Professor of Cancer Research; Director, Personalized Cancer Medicine; Medical Oncologist

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: July 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2013
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

US (4)