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TerminatedPhase 2NCT00391586
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedErlotinib and Platinum-based chemotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 17, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?New Mexico Cancer Research Alliance

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
New Mexico Cancer Research Alliance
Interventions being studied
Drug: Erlotinib; Drug: Platinum-based chemotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Lovelace Medical GroupAlbuquerque, New Mexico
  • Hematology Oncology Associates NMAlbuquerque, New Mexico
  • Presbyterian Medical GroupAlbuquerque, New Mexico
  • University of New Mexico Cancer CenterAlbuquerque, New Mexico
  • New Mexico Cancer Care AssociatesSanta Fe, New Mexico

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 17, 2015. Always confirm current availability with the study team.

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