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

NCT00391586 | Terminated Phase 2 Results DMC

• 2 other identifiers: INST 0601CNCI-2012-01264
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

erlotinib; NSCLC; chemotherapy; platinum; lung; lung cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS)

  5 years

• 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

Study Arms (1)

Erlotinib followed by chemotherapy

EXPERIMENTAL

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: 1. Docetaxel 75 mg/m2, D1 2. Docetaxel 35 mg/m2, D1,8,15 3. Paclitaxel 200-225 mg/m2, D1 4. 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: 1. Etoposide 100 mg/m2 D1-3 2. Etoposide 200 mg/m2 orally D1-3 3. Pemetrexed 500 mg/m2, D 1 4. Irinotecan 50 mg/m2 D1,8,15 Other regimens: 1. Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8 2. Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1

Drug: Erlotinib; Drug: Platinum-based chemotherapy

Interventions

Erlotinib DRUG

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

Also known as: Tarceva, OSI-774

Erlotinib followed by chemotherapy

Platinum-based chemotherapy DRUG

Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles

Also known as: paclitaxel + platinum, docetaxel + platinum, vinorelbine + platinum, pemetrexed + platinum, irinotecan + platinum, etoposide + platinum, gemcitabine + platinum

Erlotinib followed by chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• Genentech, Inc.: collaborator

Study Sites (5)

Lovelace Medical Group

Albuquerque, New Mexico, 87102, United States

Location

Hematology Oncology Associates NM

Albuquerque, New Mexico, 87106, United States

Location

Presbyterian Medical Group

Albuquerque, New Mexico, 87110, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

Related Links

• UNM CRTC Homepage

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Erlotinib Hydrochloride; Platinum Compounds; Paclitaxel; Platinum; Docetaxel; Vinorelbine; Pemetrexed; Irinotecan; Etoposide; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Inorganic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Metals, Heavy; Elements; Transition Elements; Metals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Camptothecin; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dennie Jones, MD
• Organization: Dana Farber Cancer Institute

DennieV_Jones@DFCI.HARVARD.EDU

617-632-6478

Study Officials

• Dennie V Jones, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: July 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: August 17, 2015
• Results First Posted: August 17, 2015

Record last verified: 2015-08

Locations

US (5)