NCT00330746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

May 26, 2006

Last Update Submit

May 17, 2012

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

elderlychemotherapytargeted therapycombination therapysequential therapyrandomized phase IIone year survival

Outcome Measures

Primary Outcomes (1)

  • one year survival rate

    one year

Secondary Outcomes (4)

  • toxicity

    weekly

  • overall survival

    18 months

  • overall response rate

    one year

  • prognostic role of cetuximab associated skin toxicities

    one year

Study Arms (2)

A

EXPERIMENTAL

cetuximab and gemcitabine combination

Drug: cetuximabDrug: gemcitabine

B

EXPERIMENTAL

gemcitabine followed by cetuximab (sequential)

Drug: gemcitabineDrug: cetuximab

Interventions

cetuximabDRUG

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

A
gemcitabineDRUG

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Azienda Sanitaria S. Giuseppe Moscati

Monteforte Irpino, AV, 83024, Italy

Location

Ospedale A. Cardarelli

Campobasso, CB, 86100, Italy

Location

Università di Chieti

Chieti, CH, 66013, Italy

Location

Ospedale Umberto di Frosinone

Frosinone, FR, 03031, Italy

Location

Ospedale Villa Scassi

Genova, GE, 16100, Italy

Location

Ospedale di Gaeta

Gaeta, LT, 04024, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, ME, 98148, Italy

Location

Ospedale S. Giuseppe

Milan, MI, 20100, Italy

Location

Istituto Scientifico S. Raffaele

Milan, MI, 20132, Italy

Location

Ospedale S. Paolo

Milan, MI, 20142, Italy

Location

Ospedale S. Gerado

Monza, MI, 20052, Italy

Location

Azienda Ospedaliera C. Poma

Mantova, MN, 46100, Italy

Location

Policlinico Giaccone

Palermo, PA, 90127, Italy

Location

Ospedale di Prato

Prato, PO, 59100, Italy

Location

Ospedale S. Croce

Fano, PS, 61032, Italy

Location

Ospedale S. Salvatore

Pesaro, PU, 61100, Italy

Location

Ospedale Civile Umberto I

Nocera Inferiore, SA, 84014, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, SI, 53100, Italy

Location

Ospedale E. Morelli

Sondalo, SO, 23039, Italy

Location

Presidio Ospedaliaro Alto Gardo e Ledro

Arco, TN, 38062, Italy

Location

Ospedale S. Chiara

Trento, TN, 38100, Italy

Location

Azienda Ospedaliera Di Busto Arsizio

Saronno, VA, 21047, Italy

Location

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

Noale, VE, 30033, Italy

Location

Azienda Ospedaliera Cardarelli

Napoli, 80131, Italy

Location

Second University of Naples

Napoli, 80131, Italy

Location

Related Publications (2)

  • 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)

    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.

    PMID: 19380175RESULT

MeSH Terms

Interventions

CetuximabGemcitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

November 1, 2005

Primary Completion

January 1, 2008

Study Completion

June 1, 2008

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

IT(25)