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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Platinum-based chemotherapy
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring erlotinib, NSCLC, chemotherapy, platinum, lung, lung cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lovelace Medical Group
  • Hematology Oncology Associates NM
  • Presbyterian Medical Group
  • University of New Mexico Cancer Center
  • New Mexico Cancer Care Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib followed by chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2006
Last Updated
August 14, 2015
Sponsor
New Mexico Cancer Care Alliance
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00391586
Brief Title
Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
PI left institution.
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
erlotinib, NSCLC, chemotherapy, platinum, lung, lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib followed by chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva, OSI-774
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Platinum-based chemotherapy
Other Intervention Name(s)
paclitaxel + platinum, docetaxel + platinum, vinorelbine + platinum, pemetrexed + platinum, irinotecan + platinum, etoposide + platinum, gemcitabine + platinum
Intervention Description
Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Time Frame
5 years
Title
Toxicity Profile
Description
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.
Time Frame
28 days after last on-study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennie V Jones, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovelace Medical Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Hematology Oncology Associates NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Presbyterian Medical Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.unm.edu
Description
UNM CRTC Homepage

Learn more about this trial

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

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