Trial | NCT00466284  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    erlotinib ...

  • Study Participants

    46
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
Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008
Study Started
Jan 31
2006
Last Update
Apr 27
2007
Estimate

Drug Tarceva (erlotinib)

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.
No Results Posted