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
  Purpose

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 Intervention Phase
Advanced Non-Small Cell Lung Cancer
Drug: cetuximab
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • one year survival rate [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: November 2005
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330746

Locations
Italy
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
Istituto Scientifico S. Raffaele
Milano, MI, Italy, 20132
Ospedale S. Giuseppe
Milano, MI, Italy, 20100
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
Investigators
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
  More Information

Publications:
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
ClinicalTrials.gov Identifier: NCT00330746     History of Changes
Other Study ID Numbers: CALC-1, 2004-002811-98
Study First Received: May 26, 2006
Last Updated: May 17, 2012
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 21, 2014