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Small Cell Lung CancerPhase 1/2G-StepNCT00401609

G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

A Phase 1/2 study testing gemcitabine, vinorelbine and cisplatin in people with Small Cell Lung Cancer, run by National Cancer Institute, Naples at 21 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 describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
gemcitabine, vinorelbine and cisplatin
How many people
85 participants
Where
21 sitesItaly
Study dates
Nov 2000to Feb 2009
Phase
Phase 1/2
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologic or cytologic diagnosis of SCLC
  • Extensive disease
  • Measurable disease
  • Performance Status (ECOG) < o = 2
  • Age > o = 70 years.
  • Written informed consent.

Who cannot join

  • Previous chemotherapy.
  • Previous or concomitant malignancies (with the exception of adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix)
  • •Neutrophils<2.000/mm3;platelets<100.000/mm3; hemoglobin < 10 g/dl
  • Creatinine > 1.5 time the upper limit
  • AST, ALT > 2.5 times and/or bilirubin > 1.5 time the upper limit of normal if liver metastases are absent or AST, ALT ³5 times and bilirubin > 3 times the upper limit of normal if liver metastases are present
  • Symptomatic brain metastases

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Italy21 sites

  • IRCCS Oncologico Bari, Oncologia Medica

    Bari, BA, 70126

  • Ospedale A. Cardarelli

    Campobasso, CB, 86100

  • Ospedale Mariano Santo, U.O. di Oncologia Medica

    Cosenza, CS, 87100

  • Ospedale Umberto di Frosinone

    Frosinone, FR, 03031

  • Umberto I SS. Trinita' Ospedale

    Frosinone, FR

  • Ospedale San Martino

    Genova, GE

  • Ospedale Serbelloni

    Gorgonzola, MI

  • Ospedale L. Sacco

    Milan

  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

    Monteforte Irpino, AV, 83024

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Ospedale Monaldi

    Naples

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

    Noale, VE, 30033

  • Istituto Oncologico Veneto

    Padova, PD

  • Policlinico Universitario P. Giaccone

    Palermo, PA, 90100

  • Ospedale La ferla

    Palermo, PA

  • Policlinico Giaccone

    Palermo, PA

  • Ospedale Civile

    Polla, SA

  • Azienda Sanitaria Locale 2

    Pozzuoli

  • Istituto Regina Elena, Divisione di Oncologia Medica

    Roma, Roma, 00144

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma, Roma, 00186

  • Ospedale San Camillo - Forlanini

    Rome

Other trials in Italy

About this study

Official title: Evaluation of Activity and Toxicity of Polychemotherapy With 2-drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer

The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.

Read the detailed description

Four treatment arms are planned.

  • GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 \& 8, every 21 days
  • GEMCAR: gemcitabine 1000 on days 1 \& 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1, every 21 days
  • GEMCIS: gemcitabine 1000 mg/m2 on days 1 \& 8 and cisplatin 50 or 60 or 70 mg/m2 on day 1, every 21 days
  • GEMETO: gemcitabine 1000 mg/m2 on days 1 \& 8 and etoposide 60 or 70 or 80 mg/m2 on days 1,2,3 every 21 days

For the study of the GEMVIN combination a two-stage minimax flexible design will be applied. For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at looking for optimal dose within a Bayesian framework will be applied.

Keywords
elderly
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

What is being measured

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

  1. to evaluate activity and toxicity of GEMVIN combination

  2. to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations

  3. to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations

Secondary outcomes (3)

  1. treatment impact on patient quality of life

  2. prognostic value of ADL and IADL multidimensional geriatric evaluation scales

  3. clinical variables predictive of response to treatment

Timeline

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

  1. First posted20 Nov 2006 (estimated)
  2. Study startNov 2000
  3. Primary completionDec 2007
  4. Study completionFeb 2009

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401609
Sponsor's protocol ID
G-Step
Acronym
G-Step
Status last verified
Jan 2016
First submitted
17 Nov 2006
Last updated
14 Jan 2016
Results posted
No

Publications

  • Gridelli C, Gallo C, Morabito A, Iaffaioli RV, Favaretto A, Isa L, Barbera S, Gamucci T, Ceribelli A, Filipazzi V, Maione P, Rossi A, Barletta E, Signoriello S, De Maio E, Piccirillo MC, Di Maio M, Rocco G, Vecchione A, Perrone F; G-STEP Investigators. Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial. J Thorac Oncol. 2012 Jan;7(1):233-42. doi: 10.1097/JTO.0b013e318233d6c2.

    PubMed 22031232

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing gemcitabine, vinorelbine and cisplatin in people with Small Cell Lung Cancer, run by National Cancer Institute, Naples at 21 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 6 inclusion and 6 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

to evaluate activity and toxicity of GEMVIN combination. The study lists 3 primary outcomes in all. 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 NCT00401609, which also lists 1 linked publication.

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 14 Jan 2016.

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