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

NCT ID: NCT00330746

Last Updated: 2012-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-06-30

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.

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

Conditions

Advanced Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

cetuximab and gemcitabine combination

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: DRUG

400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression

gemcitabine

Intervention Type: DRUG

1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles

B

gemcitabine followed by cetuximab (sequential)

Group Type: EXPERIMENTAL

gemcitabine

Intervention Type: DRUG

1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles

cetuximab

Intervention Type: DRUG

400 mg/m2 first dose followed by 250 mg/m2 weekly

Interventions

cetuximab

400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression

Intervention Type: DRUG

gemcitabine

1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles

Intervention Type: DRUG

gemcitabine

1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles

Intervention Type: DRUG

cetuximab

400 mg/m2 first dose followed by 250 mg/m2 weekly

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesare Gridelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

Fortunato Ciardiello, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Second Univesity of Naples, Italy; Chair Medical Oncology

Francesco Perrone, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute Naples, Italy; Director Clinical Trials Unit

Ciro Gallo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Second University of Naples, Italy; Chair of Medical Statistics

Locations

Azienda Sanitaria S. Giuseppe Moscati

Monteforte Irpino, AV, Italy

Ospedale A. Cardarelli

Campobasso, CB, Italy

Università di Chieti

Chieti, CH, Italy

Ospedale Umberto di Frosinone

Frosinone, FR, Italy

Ospedale Villa Scassi

Genova, GE, Italy

Ospedale di Gaeta

Gaeta, LT, Italy

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, ME, Italy

Ospedale S. Giuseppe

Milan, MI, Italy

Istituto Scientifico S. Raffaele

Milan, MI, Italy

Ospedale S. Paolo

Milan, MI, Italy

Ospedale S. Gerado

Monza, MI, Italy

Azienda Ospedaliera C. Poma

Mantova, MN, Italy

Policlinico Giaccone

Palermo, PA, Italy

Ospedale di Prato

Prato, PO, Italy

Ospedale S. Croce

Fano, PS, Italy

Ospedale S. Salvatore

Pesaro, PU, Italy

Ospedale Civile Umberto I

Nocera Inferiore, SA, Italy

Azienda Ospedaliera Universitaria Senese

Siena, SI, Italy

Ospedale E. Morelli

Sondalo, SO, Italy

Presidio Ospedaliaro Alto Gardo e Ledro

Arco, TN, Italy

Ospedale S. Chiara

Trento, TN, Italy

Azienda Ospedaliera Di Busto Arsizio

Saronno, VA, Italy

Divisione di Oncologia Medica, U.S.L.L. 13

Noale, VE, Italy

Azienda Ospedaliera Cardarelli

Napoli, , Italy

Second University of Naples

Napoli, , Italy

Countries

Italy

References

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)

Reference Type: RESULT

Gridelli C, Morabito A, Gebbia V, Mencoboni M, Carrozza F, Vigano MG, Verusio C, Bollina R, Mattioli R, Valerio MR, Valmadre G, Maione P, Rossi A, Cascone T, Morgillo F, Di Maio M, Piccirillo MC, Gallo C, Perrone F, Ciardiello F. Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E and CALC1-PS2) randomized phase II trials. Lung Cancer. 2010 Jan;67(1):86-92. doi: 10.1016/j.lungcan.2009.03.021.

Reference Type: RESULT

PMID: 19380175 (View on PubMed)

Other Identifiers

2004-002811-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CALC-1

Identifier Type: -

Identifier Source: org_study_id