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

G

Grupo Gallego de Cancer de Pulmon

Status and phase

Unknown
Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Tarceva (erlotinib)

Study type

Interventional

Funder types

Other

Identifiers

NCT00466284
GGCP023/05-ML19497

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

Joaquin Casal, MD

Data sourced from clinicaltrials.gov

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