Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
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ClinicalTrials.gov Identifier: NCT00391586 |
Recruitment Status :
Terminated
(PI left institution.)
First Posted : October 24, 2006
Results First Posted : August 17, 2015
Last Update Posted : August 17, 2015
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung | Drug: Erlotinib Drug: Platinum-based chemotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
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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:
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Drug: Erlotinib
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:
Drug: Platinum-based chemotherapy Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
Other Names:
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- Progression-free Survival (PFS) [ Time Frame: 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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):
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Adequate bone marrow function:
- Absolute neutrophil count >1000/µL
- Platelet count >100'000/µL
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Renal function:
- Serum creatinine < 2.0 mg %
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391586
United States, New Mexico | |
Lovelace Medical Group | |
Albuquerque, New Mexico, United States, 87102 | |
Hematology Oncology Associates NM | |
Albuquerque, New Mexico, United States, 87106 | |
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 |
Principal Investigator: | Dennie V Jones, MD | University of New Mexico |
Responsible Party: | New Mexico Cancer Care Alliance |
ClinicalTrials.gov Identifier: | NCT00391586 |
Other Study ID Numbers: |
INST 0601C NCI-2012-01264 ( Registry Identifier: NCI CTRP ) |
First Posted: | October 24, 2006 Key Record Dates |
Results First Posted: | August 17, 2015 |
Last Update Posted: | August 17, 2015 |
Last Verified: | August 2015 |
erlotinib NSCLC chemotherapy |
platinum lung lung cancer |
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine Paclitaxel |
Etoposide Vinorelbine Docetaxel Irinotecan Pemetrexed Erlotinib Hydrochloride Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |