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)

May 17, 2012 updated by: National Cancer Institute, Naples

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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: B
gemcitabine followed by cetuximab (sequential)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
one year survival rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 18 months
18 months
overall response rate
Time Frame: one year
one year
toxicity
Time Frame: weekly
weekly
prognostic role of cetuximab associated skin toxicities
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Fortunato Ciardiello, M.D., Ph.D, Second Univesity of Naples, Italy; Chair Medical Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALC-1
  • 2004-002811-98 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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