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Advanced Non-Small Cell Lung CancerPhase 2CALC-1NCT00330746

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

A Phase 2 study testing cetuximab and gemcitabine in people with Advanced Non-Small Cell Lung Cancer, run by National Cancer Institute, Naples at 25 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
cetuximab and gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
25 sitesItaly
Study dates
Nov 2005to Jun 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

  • Presidio Ospedaliaro Alto Gardo e Ledro

    Arco, TN, 38062

  • Ospedale A. Cardarelli

    Campobasso, CB, 86100

  • Università di Chieti

    Chieti, CH, 66013

  • Ospedale S. Croce

    Fano, PS, 61032

  • Ospedale Umberto di Frosinone

    Frosinone, FR, 03031

  • Ospedale di Gaeta

    Gaeta, LT, 04024

  • Ospedale Villa Scassi

    Genova, GE, 16100

  • Azienda Ospedaliera C. Poma

    Mantua, MN, 46100

  • Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, ME, 98148

  • Ospedale S. Giuseppe

    Milan, MI, 20100

  • Istituto Scientifico S. Raffaele

    Milan, MI, 20132

  • Ospedale S. Paolo

    Milan, MI, 20142

  • Azienda Sanitaria S. Giuseppe Moscati

    Monteforte Irpino, AV, 83024

  • Ospedale S. Gerado

    Monza, MI, 20052

  • Azienda Ospedaliera Cardarelli

    Naples, 80131

  • Second University of Naples

    Naples, 80131

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

    Noale, VE, 30033

  • Ospedale Civile Umberto I

    Nocera Inferiore, SA, 84014

  • Policlinico Giaccone

    Palermo, PA, 90127

  • Ospedale S. Salvatore

    Pesaro, PU, 61100

  • Ospedale di Prato

    Prato, PO, 59100

  • Azienda Ospedaliera Di Busto Arsizio

    Saronno, VA, 21047

  • Azienda Ospedaliera Universitaria Senese

    Siena, SI, 53100

  • Ospedale E. Morelli

    Sondalo, SO, 23039

  • Ospedale S. Chiara

    Trento, TN, 38100

Other trials in Italy

About this 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.

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.

Read the 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

Being tested
cetuximab, gemcitabine
Keywords
elderly, chemotherapy, targeted therapy, combination therapy, sequential therapy, randomized phase II, one year survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabDrug

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

  • gemcitabineDrug

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

  • gemcitabineDrug

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

  • cetuximabDrug

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

Study groups in NCT00330746
Study groupRoleWhat they receive
AExperimentalcetuximab and gemcitabine combination
Receives: Drug: cetuximab; Drug: gemcitabine
BExperimentalgemcitabine followed by cetuximab (sequential)
Receives: Drug: gemcitabine; Drug: cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. one year survival rate

    Measured: one year

Secondary outcomes (4)

  1. toxicity

    Measured: weekly

  2. overall survival

    Measured: 18 months

  3. overall response rate

    Measured: one year

  4. prognostic role of cetuximab associated skin toxicities

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJan 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00330746
Sponsor's protocol ID
CALC-1
Other IDs
2004-002811-98, 2004
Acronym
CALC-1
Status last verified
May 2012
First submitted
26 May 2006
Last updated
18 May 2012
Results posted
No
Data monitoring committee
No

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)

  • 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.

    PubMed 19380175

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and gemcitabine in people with Advanced Non-Small Cell Lung Cancer, run by National Cancer Institute, Naples at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

one year survival rate (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00330746, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.

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