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

National Cancer Institute, Naples

Status and phase

Completed

Phase 2

Conditions

Advanced Non-Small Cell Lung Cancer

Treatments

Drug: gemcitabine

Drug: cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00330746

CALC-1

2004-002811-98 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 patients including the elderly, those whose general condition is poor. Combining chemotherapy with a biologic agent ("targeted therapy") is a new strategy being evaluated for the treatment of NSCLC, and cetuximab is one of the drugs that has shown promise for its activity and tolerability. This study aims to determine the more promising of 2 methods of combining gemcitabine with cetuximab (in combination vs. sequential administration), in two groups of patients who are not candidates for combination platinum based chemotherapy: patients under age 70 with performance status 2 (expected enrollment 42) , and patients over age 70 (expected enrollment 58).

Patients will be randomly assigned to one of two treatment arms:

Arm A: Cetuximab + Gemcitabine:
- Cetuximab given intravenously weekly AND
- Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle)
Arm B: Gemcitabine followed by Cetuximab:
- Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle) THEN
- Cetuximab given intravenously weekly

In Arm B, Cetuximab is administered as maintenance therapy when there has been an objective response to chemotherapy, or as second line therapy in patients who had disease progression during chemotherapy

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)