Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Erlotinib; Drug: Platinum-based chemotherapy	Phase 2

Detailed Description:

To compare the activities (the progression-free survival, the incidence and severity of toxicities, and reversibility of toxicities) of erlotinib to that of platinum-based therapy in NSCLC. A sequential therapy design has been chosen such that all patients will receive any potential benefits of both platinum-based and erlotinib therapy, without compromising survival by denying anyone potential therapy. With this design, progression-free survival will be tracked by treatment received. However, data will be generated which will show the safety and efficacy of erlotinib in the frontline setting (alone and with historical comparison to platinum-based therapy), as well as the potential safety and activity of platinum-based therapy in the "second-line" (post-erlotinib) setting. This should allow for the demonstration of the relative median time to progression, objective response and clinical benefit rates, overall survival, and safety and tolerability of erlotinib and platinum-based therapy in both the frontline and second-line settings in NSCLC. Also, in this fashion, the treatments serve as controls for each other, as well as being compared to historical controls; in the first line treatment portion, the platinum-based regimens serve as the historical control, while in the second-line setting, erlotinib serves as the historical control arm.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
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

Arms and Interventions

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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: Docetaxel 75 mg/m2, D1; Docetaxel 35 mg/m2, D1,8,15; Paclitaxel 200-225 mg/m2, D1; Paclitaxel 80-100 mg/m2, D1,8,15 Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following: Etoposide 100 mg/m2 D1-3; Etoposide 200 mg/m2 orally D1-3; Pemetrexed 500 mg/m2, D 1; Irinotecan 50 mg/m2 D1,8,15 Other regimens: Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8; Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1

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: Tarceva; OSI-774 Drug: Platinum-based chemotherapy; Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles; Other Names: paclitaxel + platinum; docetaxel + platinum; vinorelbine + platinum; pemetrexed + platinum; irinotecan + platinum; etoposide + platinum; gemcitabine + platinum

Outcome Measures

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Primary Outcome Measures :

1. Progression-free Survival (PFS) [ Time Frame: 5 years ]
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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 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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

New Mexico Cancer Care Alliance

Genentech, Inc.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

UNM CRTC Homepage 

Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00391586 History of Changes
Other Study ID Numbers:	INST 0601C; NCI-2012-01264 ( Registry Identifier: NCI CTRP )
First Posted:	October 24, 2006
Results First Posted:	August 17, 2015
Last Update Posted:	August 17, 2015
Last Verified:	August 2015

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; 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; Paclitaxel; Irinotecan	Etoposide; Vinorelbine; Docetaxel; Gemcitabine; Etoposide phosphate; Erlotinib Hydrochloride; Pemetrexed; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites