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

Advanced Non-Small Cell Lung Cancer Clinical Trial

— CALC-1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330746
• Other study ID #: CALC-1
• Secondary ID: 2004-002811-98
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2006
• Last updated: May 17, 2012
• Start date: November 2005
• Est. completion date: June 2008

Study information

• Verified date: May 2012
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• cetuximab
400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression
• gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles
• gemcitabine
1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles
• cetuximab
400 mg/m2 first dose followed by 250 mg/m2 weekly

Locations

Country	Name	City	State
Italy	Presidio Ospedaliaro Alto Gardo e Ledro	Arco	TN
Italy	Ospedale A. Cardarelli	Campobasso	CB
Italy	Università di Chieti	Chieti	CH
Italy	Ospedale S. Croce	Fano	PS
Italy	Ospedale Umberto di Frosinone	Frosinone	FR
Italy	Ospedale di Gaeta	Gaeta	LT
Italy	Ospedale Villa Scassi	Genova	GE
Italy	Azienda Ospedaliera C. Poma	Mantova	MN
Italy	Azienda Ospedaliera Universitaria Policlinico G. Martino	Messina	ME
Italy	Istituto Scientifico S. Raffaele	Milano	MI
Italy	Ospedale S. Giuseppe	Milano	MI
Italy	Ospedale S. Paolo	Milano	MI
Italy	Azienda Sanitaria S. Giuseppe Moscati	Monteforte Irpino	AV
Italy	Ospedale S. Gerado	Monza	MI
Italy	Azienda Ospedaliera Cardarelli	Napoli
Italy	Second University of Naples	Napoli
Italy	Divisione di Oncologia Medica, U.S.L.L. 13	Noale	VE
Italy	Ospedale Civile Umberto I	Nocera Inferiore	SA
Italy	Policlinico Giaccone	Palermo	PA
Italy	Ospedale S. Salvatore	Pesaro	PU
Italy	Ospedale di Prato	Prato	PO
Italy	Azienda Ospedaliera Di Busto Arsizio	Saronno	VA
Italy	Azienda Ospedaliera Universitaria Senese	Siena	SI
Italy	Ospedale E. Morelli	Sondalo	SO
Italy	Ospedale S. Chiara	Trento	TN

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Gridelli C, Morabito A, Gebbia V, Mencoboni M, Carrozza F, Viganò 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 — View Citation

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 pha

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one year survival rate		one year	No
Secondary	toxicity		weekly	Yes
Secondary	overall survival		18 months	No
Secondary	overall response rate		one year	No
Secondary	prognostic role of cetuximab associated skin toxicities		one year	No