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Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy

Primary Purpose

Non Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
erlotinib
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring EGFR expression, erlotinib

Eligibility Criteria

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

Inclusion Criteria:

  • Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
  • Chemo-naïve patients.
  • Patients who are in the investigator's opinion not medically suitable for chemotherapy.
  • Measurable disease according to the RECIST criteria.
  • ECOG performance status of 0 - 3.
  • Life expectancy of at least 12 weeks.
  • Patients must be able to take oral medication.
  • Serum calcium within normal ranges
  • ≥ 4 weeks since prior surgery or radiation therapy
  • For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
  • 18 years of age or older
  • Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

  • Prior systemic antitumor therapy
  • Any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x ULN.
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Nursing mothers or pregnant woman.
  • Hypersensitivity to Tarceva or co-formulants.
  • Patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
  • Patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.

Sites / Locations

  • Department of Oncology, Rigshospitalet
  • Department of Oncology, Odense University Hospital
  • Department of Oncology, Århus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

arm 1 medicine

Arm Description

erlotinib daily

Outcomes

Primary Outcome Measures

Disease control rate

Secondary Outcome Measures

To investigate the tolerability and safety of erlotinib in patients, who can not receive chemotherapy, by registration of side-effects.
Correlation of EGFR expression rate and FISH potentially predictive for response

Full Information

First Posted
March 23, 2007
Last Updated
December 10, 2014
Sponsor
Rigshospitalet, Denmark
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00452075
Brief Title
Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy
Official Title
A Phase II Study of Erlotinib and Predictive Markers as First-line Treatment of Advanced Non-small Cell Lung Cancer for Patients Unfit for Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for response. An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1 will accrue 10 patients, if less than 1 response is observed the study will stop; if more than 1 response is observed the accrual will continue up till 29 patients. A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
EGFR expression, erlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm 1 medicine
Arm Type
Experimental
Arm Description
erlotinib daily
Intervention Type
Drug
Intervention Name(s)
erlotinib
Other Intervention Name(s)
tarceva
Intervention Description
150mg daily
Primary Outcome Measure Information:
Title
Disease control rate
Time Frame
2010
Secondary Outcome Measure Information:
Title
To investigate the tolerability and safety of erlotinib in patients, who can not receive chemotherapy, by registration of side-effects.
Time Frame
2010
Title
Correlation of EGFR expression rate and FISH potentially predictive for response
Time Frame
2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC. Chemo-naïve patients. Patients who are in the investigator's opinion not medically suitable for chemotherapy. Measurable disease according to the RECIST criteria. ECOG performance status of 0 - 3. Life expectancy of at least 12 weeks. Patients must be able to take oral medication. Serum calcium within normal ranges ≥ 4 weeks since prior surgery or radiation therapy For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception 18 years of age or older Written (signed) Informed Consent to participate in the study Exclusion Criteria: Prior systemic antitumor therapy Any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x ULN. Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). Nursing mothers or pregnant woman. Hypersensitivity to Tarceva or co-formulants. Patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation. Patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pappot Helle, MD, DMSC
Organizational Affiliation
Department of Oncology, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Department of Oncology, Århus University Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy

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