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

This study has been terminated.
(PI left institution.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00391586
First received: October 23, 2006
Last updated: August 14, 2015
Last verified: August 2015
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Erlotinib
Drug: Platinum-based chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity Profile [ Time Frame: 28 days after last on-study treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 45
Study Start Date: July 2006
Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391586

Locations
United States, New Mexico
Hematology Oncology Associates NM
Albuquerque, New Mexico, United States, 87106
Lovelace Medical Group
Albuquerque, New Mexico, United States, 87102
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

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00391586     History of Changes
Other Study ID Numbers: INST 0601C, NCI-2012-01264
Study First Received: October 23, 2006
Results First Received: June 15, 2015
Last Updated: August 14, 2015
Health Authority: United States: Institutional Review Board

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 27, 2015