Efficacy and Safety of Cetuximab in Combination With Cisplatin Gemcitabine as First-Line Therapy in Advanced NSCLC

NCT00561054 | Unknown Phase 2

• 1 other identifier: 2006-000537-35
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of cancer deaths worldwide. It is estimated that, in 2004, 173,700 new cases of lung cancer will be diagnosed in the United States alone and 164,440 deaths due to this disease will occur(13) . NSCLC accounts for approximately 80% of all lung cancers. Among NSCLC cases approximately 30% present with locally advanced and 40% with metastatic disease (14,15) . In metastatic disease, chemotherapy is the treatment of choice, but benefits obtained in survival have been modest. Five-year survival is less than 15%, probably due to diagnosis at late stages. Surgical results in earlier stages are poor compared to other tumor types (about 40% of recurrence in stages I-II). Results of chemotherapy in advanced stages are also poor (one-year survival of 40%) (15,17). It is commonly accepted that the standard treatment for advanced disease (stage IV and IIIb with malignant pleural effusion) consists of platinum-based chemotherapy(15,16) . However, there are many open questions in the management of these patients, such as the role of 3-drugs combinations, non-platinum-based therapies, and new biologic therapeutics' approaches. Currently, in the treatment of advanced NSCLC response rates of about 20%-30% and median survival times of 6 to 11 months have been achieved (16, 17, 18, 19, 20, 21, 22,). Several combinations of drugs are used and show similar efficacy. Cisplatin plus vinorelbine or Cisplatin plus Gemcitabine are among the most commonly used regimens in the first-line therapy of NSCLC.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Coimbra; NSCLC; CETUXIMAB

Outcome Measures

Primary Outcomes (1)

• oVERALL RESPONSE RATE

  30/11/2009

Secondary Outcomes (1)

• tIME TO PROGRESSION oVERALL SORVIVAL SAFETY

  30/11/2009

Study Arms (1)

1

NO INTERVENTION

CISPLATIN gENCITABINE cETUXIMAB

Drug: CETUXIMAB

Interventions

CETUXIMAB DRUG

400 mg/m2 starting dose, 250 mg/m2 weekly dose

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Portugues de Estudo do Cancro do Pulmao: lead

Study Sites (1)

fERNANDO bARATA

Coimbra, Coimbra District, 3040, Portugal

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Fernando Barata, MD

  Grupo Portugues de Estudo do Cancro do Pulmao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Barata, MD

CONTACT

00351239 800 195; fjssbarata@sapo.pt

Agostinho Costa, MD

CONTACT

00351 21 7548032; costa.agostinho@clix.pt

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: March 1, 2007
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

PT (1)