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

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 Drug: Intravenous chemotherapy	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

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 ]


Enrollment:	54
Study Start Date:	July 2006
Study Completion Date:	May 2012
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Erlotinib Erlotinib -- 150 mg tablet QD	Drug: Erlotinib 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. Other Name: Tarceva Drug: Erlotinib Erlotinib -- 150 mg tablet QD Other Names: Randomized Erlotinib Arm for possibly 6 cycles but at least 2 cycles. Each cycle = 21 days. Erlotinib = 150 mg PO QD. After 6 cycles SOC platinum-based chemotherapy will be given to patients based on individual response and physician discretion. If disease progression occurs, SOC platinum-based chemotherapy is initiated.
Active Comparator: 2 IV Chemotherapy Regime Combination per Physician discretion Q3Weeks	Drug: Intravenous chemotherapy IV Chemotherapy Regime Combination per Physician discretion Q3Weeks

Arms

Assigned Interventions

Experimental: Erlotinib

Erlotinib -- 150 mg tablet QD

Drug: Erlotinib

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.

Other Name: Tarceva

Drug: Erlotinib

Erlotinib -- 150 mg tablet QD

Other Names:

Randomized Erlotinib Arm for possibly 6 cycles but at least 2 cycles.
Each cycle = 21 days.
Erlotinib = 150 mg PO QD.
After 6 cycles SOC platinum-based chemotherapy will be given to patients
based on individual response and physician discretion.
If disease progression occurs, SOC platinum-based chemotherapy is initiated.

Active Comparator: 2

IV Chemotherapy Regime Combination per Physician discretion Q3Weeks

Drug: Intravenous chemotherapy

IV Chemotherapy Regime Combination per Physician discretion Q3Weeks

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, New Mexico
Hematology Oncology Associates NM
Albuquerque, New Mexico, United States, 87106
Lovelace Medical Group
Albuquerque, New Mexico, United States, 87102
Presbyterian Medical Group
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505

Sponsors and Collaborators

New Mexico Cancer Care Alliance

Genentech, Inc.

Investigators


Principal Investigator:	Dennie V Jones, MD	University of New Mexico

More Information

Additional Information:

UNM CRTC Homepage This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00391586 History of Changes
Other Study ID Numbers:	INST 0601C
Study First Received:	October 23, 2006
Last Updated:	October 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:


erlotinib NSCLC chemotherapy	platinum lung lung cancer

Additional relevant MeSH terms:


Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site	Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Erlotinib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on February 27, 2015