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:
National Cancer Institute, Naples
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
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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
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 May 23, 2013