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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00330746
First received: May 26, 2006
Last updated: May 17, 2012
Last verified: May 2012

May 26, 2006
May 17, 2012
November 2005
January 2008   (final data collection date for primary outcome measure)
one year survival rate [ Time Frame: one year ] [ Designated as safety issue: No ]
one year survival rate
Complete list of historical versions of study NCT00330746 on ClinicalTrials.gov Archive Site
  • toxicity [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • overall response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • prognostic role of cetuximab associated skin toxicities [ Time Frame: one year ] [ Designated as safety issue: No ]
  • toxicity
  • overall survival
  • overall response rate
  • prognostic role of cetuximab associated skin toxicities
Not Provided
Not Provided
 
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
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 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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Non-Small Cell Lung Cancer
  • Drug: cetuximab
    400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression
  • Drug: gemcitabine
    1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles
  • Drug: gemcitabine
    1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles
  • Drug: cetuximab
    400 mg/m2 first dose followed by 250 mg/m2 weekly
  • Experimental: A
    cetuximab and gemcitabine combination
    Interventions:
    • Drug: cetuximab
    • Drug: gemcitabine
  • Experimental: B
    gemcitabine followed by cetuximab (sequential)
    Interventions:
    • Drug: gemcitabine
    • Drug: cetuximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2008
January 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00330746
CALC-1, 2004-002811-98
No
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Cesare Gridelli, M.D. S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Principal Investigator: Fortunato Ciardiello, M.D., Ph.D Second Univesity of Naples, Italy; Chair Medical Oncology
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Principal Investigator: Ciro Gallo, M.D., Ph.D Second University of Naples, Italy; Chair of Medical Statistics
National Cancer Institute, Naples
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP