- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391586
Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico Cancer Center
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Albuquerque, New Mexico, United States, 87110
- Presbyterian Medical Group
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Albuquerque, New Mexico, United States, 87102
- Lovelace Medical Group
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Albuquerque, New Mexico, United States, 87106
- Hematology Oncology Associates NM
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Santa Fe, New Mexico, United States, 87505
- New Mexico Cancer Care Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erlotinib followed by chemotherapy
Erlotinib: 150 mg orally once daily, Platinum-based chemotherapy regimen selections include: Carboplatin (Carbo) area under the curve (AUC) 6, or cisplatin (Cis) 60-100 mg/m2, day (D)1, administered with one of the following:
Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following:
Other regimens:
|
Erlotinib will be administered for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or intolerance to erlotinib, standard of care platinum-based chemotherapy (per the choice of the treating physician) is administered every 3 weeks. Physicians can adjust dose, schedule, or supportive care to the benefit of the patient
Other Names:
Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: 5 years
|
5 years
|
|
Toxicity Profile
Time Frame: 28 days after last on-study treatment
|
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.
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28 days after last on-study treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dennie V Jones, MD, University Of New Mexico
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Topoisomerase I Inhibitors
- Folic Acid Antagonists
- Gemcitabine
- Docetaxel
- Etoposide
- Paclitaxel
- Erlotinib Hydrochloride
- Irinotecan
- Vinorelbine
- Pemetrexed
Other Study ID Numbers
- INST 0601C
- NCI-2012-01264 (Registry Identifier: NCI CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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