CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer, who are not candidates for platinum based therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cetuximab; Gemcitabine

Criteria

Inclusion Criteria:

• Signed written informed consent

• Age > 18

• Histological diagnosis of non small-cell lung cancer (NSCLC)

• Stage III B or Stage IV disease

• Contraindications to platinum based therapy (age > 70 or age < 70 with ECOG performance status 2)

• At least one site of metastasis (target or non-target)

• Life expectancy of at least 3 months

• ECOG <3

• Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 9g/dl

• Bilirubin < 1.5 x the upper normal limit

• SGOT and SGPT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)

• Creatinine < 1.5 x the upper normal limit

• Adequate method of contraception (male and female), when there is risk of conception.

Exclusion Criteria:

• Symptomatic cerebral metastasis

• Previous chemotherapy for advanced disease

• Adjuvant chemotherapy within the previous 6 months

• Radiation therapy within previous 4 weeks

• Any experimental drug therapy within the previous 4 weeks

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

• Clinically relevant cardiopathy or myocardial infarct within the last 12 months

• Acute or subacute intestinal occlusion or history of inflammatory bowel disease

• Known allergy to one or more of the experimental treatments

• Known alcohol or substance abuse

• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent

• Pregnant or breastfeeding females

• History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)