Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
Verified date | August 2015 |
Source | New Mexico Cancer Care Alliance |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study was conducted to compare the activities of erlotinib to that of intravenous, platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline therapy, compared to historical controls.
Status | Terminated |
Enrollment | 45 |
Est. completion date | May 2012 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 non-small cell lung cancer (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 - Eastern Cooperative Oncology Group (ECOG)/Zubrod/Southwest Oncology Group (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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hematology Oncology Associates NM | Albuquerque | New Mexico |
United States | Lovelace Medical Group | Albuquerque | New Mexico |
United States | Presbyterian Medical Group | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | New Mexico Cancer Care Associates | Santa Fe | New Mexico |
Lead Sponsor | Collaborator |
---|---|
New Mexico Cancer Care Alliance | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) | 5 years | No | |
Primary | Toxicity Profile | Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment. | 28 days after last on-study treatment | Yes |
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