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Open-Label, Uncontrolled, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cetuximab in Combination With Cisplatin & Gemcitabine as First-Line Therapy in Patients With Advanced Non Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Open-Label, Uncontrolled, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cetuximab in Combination With Cisplatin & Gemcitabine as First-Line Therapy in Patients With Advanced Non Small Cell Lung Cancer


Criteria for inclusion Signed written informed consent Male or female ≥18 years of age
Cito-histological diagnosis of NSCLC, stage IV Performance Status = 0 or 1 Measurable
disease on CT scan - RECIST criteria White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x
109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL Bilirubin level either normal or
≤1.5 x ULN ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases) Alkaline
phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases Creatinine clearance ≥ 50
ml/min Negative pregnancy test within one week before treatment start, if applicable Life
expectancy of ≥ 3 months Availability of tumor sample (or able and willing to provide tumor
sample) for EGFR assessment Effective contraception for both male and female patients if the
risk of conception exists Criteria for exclusion Documented or symptomatic brain metastases
Previous chemotherapy for NSCLC including adjuvant chemotherapy Concurrent chronic systemic
immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any
investigational agent(s) within 4 weeks prior to entry Major surgery within 4 weeks prior to
study entry Prior chest irradiation within 12 weeks prior to study entry (palliative
radiation of bone lesions is allowed) Superior vena cava syndrome contra-indicating
hydratation Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors
or EGFR targeting therapy Myocardial infraction within 6 months prior to study entry,
uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder
despite treatment Known allergic / hypersensitivity reaction to any of the components of
study treatments Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity
Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except if due
to trauma or mechanical impairment due to tumor mass Medical or psychological condition
which in the opinion of the investigator would not permit the patient to complete the study
or sign meaningful informed consent Pregnancy or breastfeeding Any previous or concurrent
malignancy other than nonmelanoma skin cancer, or carcinoma in situ of the cervix. (Patients
with a previous malignancy but without evidence of disease for > 5 years will be allowed to
enter the trial)


Inclusion Criteria:



- Signed written informed consent

- Male or female ≥18 years of age

- Cito-histological diagnosis of NSCLC, stage IV

- Performance Status = 0 or 1

- Measurable disease on CT scan - RECIST criteria

- White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x 109/L,

- platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL

- Bilirubin level either normal or ≤1.5 x ULN

- ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases)

- Alkaline phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases

- Creatinine clearance ≥ 50 ml/min

- Negative pregnancy test within one week before treatment start, if applicable

- Life expectancy of ≥ 3 months

- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR
assessment

- Effective contraception for both male and female patients if the risk of conception
exists

Exclusion Criteria:

- Documented or symptomatic brain metastases

- Previous chemotherapy for NSCLC including adjuvant chemotherapy

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol

- Any investigational agent(s) within 4 weeks prior to entry

- Major surgery within 4 weeks prior to study entry

- Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of
bone lesions is allowed)

- Superior vena cava syndrome contra-indicating hydratation

- Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or
EGFR targeting therapy

- Myocardial infraction within 6 months prior to study entry, uncontrolled congestive
heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment

- Known allergic / hypersensitivity reaction to any of the components of study
treatments

- Known drug abuse/ alcohol abuse

- Legal incapacity or limited legal capacity

- Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except
if due to trauma or mechanical impairment due to tumor mass

- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent

- Pregnancy or breastfeeding

- Any previous or concurrent malignancy other than nonmelanoma skin cancer, or
carcinoma in situ of the cervix. (Patients with a previous malignancy but without
evidence of disease for > 5 years will be allowed to enter the trial)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

oVERALL RESPONSE RATE

Outcome Time Frame:

30/11/2009

Principal Investigator

Fernando Barata, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Grupo Portugues de Estudo do Cancro do Pulmao

Authority:

Portugal: National Pharmacy and Medicines Institute

Study ID:

2006-000537-35

NCT ID:

NCT00561054

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Coimbra
  • NSCLC
  • CETUXIMAB
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

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