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


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008


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 ┬Ámol/l); AST, ALT, and Alkaline Phosphatase < 5
x normal,

- Renal:Creatinine < 1.5 mg/dl (132 ┬Ámol/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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Principal Investigator

Joquin Casal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GGCP

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GGCP023/05-ML19497

NCT ID:

NCT00466284

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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