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 - Full Text View

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00330746

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Cetuximab

U.S. FDA Resources

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
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
B: Experimental 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

Show 25 Study Locations

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 ( Francesco Perrone, Director Clinical Trials Unit )
Study ID Numbers:	CALC-1, EudraCT number 2004-002811-98
Study First Received:	May 26, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00330746 History of Changes
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

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Cetuximab
Immunosuppressive Agents
Antiviral Agents
Carcinoma

Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Cetuximab
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009