Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 plat...
Detailed Description
The standard treatment for advanced non small cell lung cancer (NSCLC) is combination chemotherapy with cisplatin or carboplatin. Due to its toxicity, this therapy may not be suited for certain patien...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00330746
Start Date
November 1 2005
End Date
June 1 2008
Last Update
May 18 2012
Active Locations (25)
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1
Azienda Sanitaria S. Giuseppe Moscati
Monteforte Irpino, AV, Italy, 83024
2
Ospedale A. Cardarelli
Campobasso, CB, Italy, 86100
3
Università di Chieti
Chieti, CH, Italy, 66013
4
Ospedale Umberto di Frosinone
Frosinone, FR, Italy, 03031