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 (CALC-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330746
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : May 18, 2012
Information provided by (Responsible Party):
National Cancer Institute, Naples

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 platinum based therapy.

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Drug: cetuximab Drug: gemcitabine Phase 2

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 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: A
cetuximab and gemcitabine combination
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

Experimental: B
gemcitabine followed by cetuximab (sequential)
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

Primary Outcome Measures :
  1. one year survival rate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: weekly ]
  2. overall survival [ Time Frame: 18 months ]
  3. overall response rate [ Time Frame: one year ]
  4. prognostic role of cetuximab associated skin toxicities [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00330746

Azienda Sanitaria S. Giuseppe Moscati
Monteforte Irpino, AV, Italy, 83024
Ospedale A. Cardarelli
Campobasso, CB, Italy, 86100
Università di Chieti
Chieti, CH, Italy, 66013
Ospedale Umberto di Frosinone
Frosinone, FR, Italy, 03031
Ospedale Villa Scassi
Genova, GE, Italy, 16100
Ospedale di Gaeta
Gaeta, LT, Italy, 04024
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, ME, Italy, 98148
Ospedale S. Giuseppe
Milano, MI, Italy, 20100
Istituto Scientifico S. Raffaele
Milano, MI, Italy, 20132
Ospedale S. Paolo
Milano, MI, Italy, 20142
Ospedale S. Gerado
Monza, MI, Italy, 20052
Azienda Ospedaliera C. Poma
Mantova, MN, Italy, 46100
Policlinico Giaccone
Palermo, PA, Italy, 90127
Ospedale di Prato
Prato, PO, Italy, 59100
Ospedale S. Croce
Fano, PS, Italy, 61032
Ospedale S. Salvatore
Pesaro, PU, Italy, 61100
Ospedale Civile Umberto I
Nocera Inferiore, SA, Italy, 84014
Azienda Ospedaliera Universitaria Senese
Siena, SI, Italy, 53100
Ospedale E. Morelli
Sondalo, SO, Italy, 23039
Presidio Ospedaliaro Alto Gardo e Ledro
Arco, TN, Italy, 38062
Ospedale S. Chiara
Trento, TN, Italy, 38100
Azienda Ospedaliera Di Busto Arsizio
Saronno, VA, Italy, 21047
Divisione di Oncologia Medica, U.S.L.L. 13
Noale, VE, Italy, 30033
Azienda Ospedaliera Cardarelli
Napoli, Italy, 80131
Second University of Naples
Napoli, Italy, 80131
Sponsors and Collaborators
National Cancer Institute, Naples
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

Publications of Results:
Gridelli D, Mencoboni M, Carrozza F, Viganò MG, Gebbia V, Verusio C, Maione P, Gallo C, Perrone F, Ciardiello F. Cetuximab (C) and gemcitabine (G) in elderly or adult PS2 advanced non small-cell lung cancer (NSCLC) patients (pts): The CALC1 randomised phase II trials. Journal of Clinical Oncology 26: 2008 (May 20 suppl; abstr 8117)

Responsible Party: National Cancer Institute, Naples Identifier: NCT00330746     History of Changes
Other Study ID Numbers: CALC-1
2004-002811-98 ( EudraCT Number )
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by National Cancer Institute, Naples:
targeted therapy
combination therapy
sequential therapy
randomized phase II
one year survival

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs