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Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Tarceva (erlotinib)

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 years.
Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
Measurable disease.
Written informed consent must be obtained prior to the inclusion into the trial.
Karnofsky performance status of 80%.
Patients must have been treated with no prior chemotherapy or radioterapy.
Patients must have adequate bone marrow, liver and renal function.
- Bone Marrow: WBC > 3000 x 103/mm3,
- Platelets > 100 x 103/mm3,
- Hgb > 10.0 gm/dl,
- ANC >1500 x 103/mm3,
- Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal,
- Renal:Creatinine < 1.5 mg/dl (132 µmol/l).

Exclusion Criteria:

Female patients who are pregnant or lactating.
Patients who have used other investigational agents within 21 days prior to study entry.
Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
Significant comorbidity.

Sites / Locations

Grupo Gallego de Cancer de PulmonRecruiting

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Progression free survival

Overall survival

Safety of Tarceva

Full Information

NCT ID

NCT00466284

First Posted

April 25, 2007

Last Updated

April 25, 2007

Sponsor

Grupo Gallego de Cancer de Pulmon

1. Study Identification

Unique Protocol Identification Number

NCT00466284

Brief Title

Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

Official Title

Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Grupo Gallego de Cancer de Pulmon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated. STUDY OBJECTIVES Primary: Objective response rate Secondary: Progression free survival, Overall survival and Safety of Tarceva

Detailed Description

Study Design: Phase II trial, open label, non-randomized and multicenter. Expected total enrollment: 46 Study start: January, 2006 Study completation: January, 2008

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tarceva (erlotinib)

Primary Outcome Measure Information:

Title

Objective response rate

Secondary Outcome Measure Information:

Title

Progression free survival

Title

Overall survival

Title

Safety of Tarceva

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 years. Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB). Measurable disease. Written informed consent must be obtained prior to the inclusion into the trial. Karnofsky performance status of 80%. Patients must have been treated with no prior chemotherapy or radioterapy. Patients must have adequate bone marrow, liver and renal function. Bone Marrow: WBC > 3000 x 103/mm3, Platelets > 100 x 103/mm3, Hgb > 10.0 gm/dl, ANC >1500 x 103/mm3, Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal, Renal:Creatinine < 1.5 mg/dl (132 µmol/l). Exclusion Criteria: Female patients who are pregnant or lactating. Patients who have used other investigational agents within 21 days prior to study entry. Patients who have received prior treatment with erlotinib or other anti-EGFR agent. Significant comorbidity.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joaquin Casal, MD

Phone

986811111

Ext

645

joaquin.casal.rubio@sergas.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joquin Casal, MD

Organizational Affiliation

GGCP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grupo Gallego de Cancer de Pulmon

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15701

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joaquin Casal, MD

joaquin.casal.rubio@sergas.es

12. IPD Sharing Statement

Citations:

PubMed Identifier

24352251

Citation

Casal Rubio J, Firvida-Perez JL, Lazaro-Quintela M, Baron-Duarte FJ, Alonso-Jaudenes G, Santome L, Afonso-Afonso FJ, Amenedo M, Huidobro G, Campos-Balea B, Lopez-Vazquez MD, Vazquez S. A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study. Cancer Chemother Pharmacol. 2014 Mar;73(3):451-7. doi: 10.1007/s00280-013-2370-z. Epub 2013 Dec 19.

Results Reference

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Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

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