Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
William Pao, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00416650
First received: December 27, 2006
Last updated: April 2, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: erlotinib hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer. |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Major objective response rate (complete response and partial response) [ Time Frame: At 4 weeks and then every 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: weekly for 4 weeks, then every 8 weeks to discontinuation of drug ] [ Designated as safety issue: Yes ]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 [ Time Frame: baseline, every week for 5 weeks, and then every 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: from study entry to date of death or last date known alive ] [ Designated as safety issue: No ]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.
| Enrollment: | 16 |
| Study Start Date: | July 2002 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Therapeutic Intervention
Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
|
Drug: erlotinib hydrochloride
All patients will receive 150 mg orally daily
Other Name: Tarceva, OSI-774
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416650
Locations
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | William Pao, MD | Vanderbilt-Ingram Cancer Center |
More Information
No publications provided
| Responsible Party: | William Pao, MD, 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, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00416650 History of Changes |
| Other Study ID Numbers: | VCC THO 0214, P50CA090949, P30CA068485, VU-VCC-THO-0214, VU-VCC-IRB-02-0168, GENENTECH-VU-VCC-THO-0214 |
| Study First Received: | December 27, 2006 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer bronchoalveolar cell lung cancer recurrent non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013