Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.
18 Years
N/A
Both
Advanced Non-Small Cell Lung Cancer
Trial Information
Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
one year survival rate
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Cesare Gridelli, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Authority:
Italy: Ethics Committee
Study ID:
CALC-1
NCT ID:
NCT00330746
Start Date:
November 2005
Completion Date:
June 2008
Related Keywords:
- Advanced Non-Small Cell Lung Cancer
- elderly
- chemotherapy
- targeted therapy
- combination therapy
- sequential therapy
- randomized phase II
- one year survival
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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