Erlotinib Versus Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung - Full Text View

Sponsors and Collaborators:	University of New Mexico Genentech
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00391586

Purpose

Primary Objective:To compare the activities of erlotinib to that of platinum-based therapy in NSCLC

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Erlotinib	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	INST 0601C: A Randomized Phase II Protocol of Erlotinib Versus Standard Platinum-Based Chemotherapy in Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

Objective tumor response, clinical benefit, tumor responses + stable disease [ Time Frame: disease progress or complete remission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To document the rate of response, median duration of response, and median overall survivals of subjects as a function of the treatment administered [ Time Frame: disease progression, unacceptable toxicities ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2006
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Erlotinib will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent Tarceva, 150 mg/day.

Detailed Description:

Primary Objective:To compare the activities(the progression-free survival, and the incidence and severity of toxicities, and reversibility of toxicities) of erlotinib to that of platinum-based therapy in NSCLC

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior chemotherapy will be allowed for other invasive malignancies, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol. No prior chemotherapy for metastatic NSCLC will be allowed. Prior adjuvant or neoadjuvant chemotherapy for NSCLC will be allowed, provided at least six months have elapsed from the last dose of chemotherapy to the documentation of relapsed disease.

Baseline laboratory values (bone marrow, renal, hepatic):

Adequate bone marrow function:
- Absolute neutrophil count >1000/µL
- Platelet count >100'000/µL
Renal function:
- Serum creatinine < 2.0 mg %
Hepatic function:
- Bilirubin <1.5x normal
- Serum calcium < 12 mg/dl

Other Eligibility Criteria:

Signed Informed Consent
ECOG/Zubrod/SWOG Performance Status <2 (Karnofsky Performance Status > 70%)
Life expectancy > 8 weeks
Male or female' age >18 years
Patients of childbearing potential must be using an effective means of contraception.
Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease

Exclusion Criteria:

Prior therapy with an epidermal growth factor receptor inhibitor, including erlotinib, gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting agent
Pregnant or lactating females
Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
Uncontrolled' clinically significant dysrhythmia
History of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix
Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
Uncontrolled metastatic disease of the central nervous system (previously treated, stable disease is allowable on this protocol)
Radiotherapy within the 2 weeks before Cycle 1' Day 1
Surgery within the 2 weeks before Cycle 1' Day 1
Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391586

Contacts

Contact: Dennis V Jones, MD	505 272-5837	dvjones@salud. unm.edu
Contact: Ian Rabinowitz, MD	505 272-5837	irabinowitz@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Leanne Gideon 505-272-5688 lgideon@salud.unm.edu
Principal Investigator: Dennie V Jones, MD

Sponsors and Collaborators

University of New Mexico

Genentech

Investigators

Principal Investigator:

Dennie V Jones, MD

University of New Mexico

More Information

UNM CRTC Clinical Trials Listing This link exits the ClinicalTrials.gov site

UNM CRTC Homepage This link exits the ClinicalTrials.gov site

Responsible Party:	University of New Mexico CRTC ( Dennie Jones, MD )
Study ID Numbers:	INST 0601C
Study First Received:	October 23, 2006
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00391586
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

erlotinib
NSCLC
chemotherapy

platinum
lung
lung cancer

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009