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CompletedNCT00401609G-StepUpdated Jan 14, 2016

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

A Phase 1/2 interventional study of gemcitabine and vinorelbine in Small Cell Lung Cancer, sponsored by National Cancer Institute, Naples. Completed at 21 sites in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-01-14.

Sponsored by National Cancer Institute, Naples · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
70 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Small Cell Lung Cancer

Keywords

  • elderly
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 85 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants

Interventions

  • Druggemcitabine
  • Drugvinorelbine
  • Drugcisplatin
  • Drugetoposide
  • Drugcarboplatin
06

What researchers measure

Primary outcomes

  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

  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

07

Study locations

21 sites
  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
    Monteforte Irpino, AV 83024, Italy
  • IRCCS Oncologico Bari, Oncologia Medica
    Bari, BA 70126, Italy
  • Ospedale A. Cardarelli
    Campobasso, CB 86100, Italy
  • Ospedale Mariano Santo, U.O. di Oncologia Medica
    Cosenza, CS 87100, Italy
  • Ospedale Umberto di Frosinone
    Frosinone, FR 03031, Italy
  • Umberto I SS. Trinita' Ospedale
    Frosinone, FR, Italy
  • Ospedale San Martino
    Genova, GE, Italy
  • Ospedale Serbelloni
    Gorgonzola, MI, Italy
  • Policlinico Universitario P. Giaccone
    Palermo, PA 90100, Italy
  • Ospedale La ferla
    Palermo, PA, Italy
  • Policlinico Giaccone
    Palermo, PA, Italy
  • Istituto Oncologico Veneto
    Padova, PD, Italy
  • Ospedale Civile
    Polla, SA, Italy
  • Divisione di Oncologia Medica, U.S.L.L. 13
    Noale, VE 30033, Italy
  • Ospedale L. Sacco
    Milano, Italy
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
    Napoli, 80131, Italy
  • Ospedale Monaldi
    Napoli, Italy
  • Azienda Sanitaria Locale 2
    Pozzuoli, Italy
  • Istituto Regina Elena, Divisione di Oncologia Medica
    Roma, 00144, Italy
  • Ospedale S. Giovanni Calibita Fatebenefratelli
    Roma, 00186, Italy
  • Ospedale San Camillo - Forlanini
    Rome, Italy
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00401609
Lead sponsor
National Cancer Institute, Naples
First posted
Nov 20, 2006
Start date
Nov 2000
Primary completion
Dec 2007
Completion
Feb 2009
Last update
Jan 14, 2016

Study contacts

Cesare Gridelli, M.D.
principal investigator · San Giuseppe Moscati Hospital, Avellino, Italy
Francesco Perrone, M.D., Ph.D.
principal investigator · National Cancer Institute Naples, Italy
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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