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

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
gemcitabine
vinorelbine
cisplatin
etoposide
carboplatin
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
  • IRCCS Oncologico Bari, Oncologia Medica
  • Ospedale A. Cardarelli
  • Ospedale Mariano Santo, U.O. di Oncologia Medica
  • Ospedale Umberto di Frosinone
  • Umberto I SS. Trinita' Ospedale
  • Ospedale San Martino
  • Ospedale Serbelloni
  • Policlinico Universitario P. Giaccone
  • Ospedale La ferla
  • Policlinico Giaccone
  • Istituto Oncologico Veneto
  • Ospedale Civile
  • Divisione di Oncologia Medica, U.S.L.L. 13
  • Ospedale L. Sacco
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
  • Ospedale Monaldi
  • Azienda Sanitaria Locale 2
  • Istituto Regina Elena, Divisione di Oncologia Medica
  • Ospedale S. Giovanni Calibita Fatebenefratelli
  • Ospedale San Camillo - Forlanini

Outcomes

Primary Outcome Measures

to evaluate activity and toxicity of GEMVIN combination
to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations
to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations

Secondary Outcome Measures

treatment impact on patient quality of life
prognostic value of ADL and IADL multidimensional geriatric evaluation scales
clinical variables predictive of response to treatment

Full Information

First Posted
November 17, 2006
Last Updated
January 13, 2016
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00401609
Brief Title
G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
Acronym
G-Step
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
carboplatin
Primary Outcome Measure Information:
Title
to evaluate activity and toxicity of GEMVIN combination
Title
to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations
Title
to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations
Secondary Outcome Measure Information:
Title
treatment impact on patient quality of life
Title
prognostic value of ADL and IADL multidimensional geriatric evaluation scales
Title
clinical variables predictive of response to treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Gridelli, M.D.
Organizational Affiliation
San Giuseppe Moscati Hospital, Avellino, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D.
Organizational Affiliation
National Cancer Institute Naples, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
City
Monteforte Irpino
State/Province
AV
ZIP/Postal Code
83024
Country
Italy
Facility Name
IRCCS Oncologico Bari, Oncologia Medica
City
Bari
State/Province
BA
ZIP/Postal Code
70126
Country
Italy
Facility Name
Ospedale A. Cardarelli
City
Campobasso
State/Province
CB
ZIP/Postal Code
86100
Country
Italy
Facility Name
Ospedale Mariano Santo, U.O. di Oncologia Medica
City
Cosenza
State/Province
CS
ZIP/Postal Code
87100
Country
Italy
Facility Name
Ospedale Umberto di Frosinone
City
Frosinone
State/Province
FR
ZIP/Postal Code
03031
Country
Italy
Facility Name
Umberto I SS. Trinita' Ospedale
City
Frosinone
State/Province
FR
Country
Italy
Facility Name
Ospedale San Martino
City
Genova
State/Province
GE
Country
Italy
Facility Name
Ospedale Serbelloni
City
Gorgonzola
State/Province
MI
Country
Italy
Facility Name
Policlinico Universitario P. Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90100
Country
Italy
Facility Name
Ospedale La ferla
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Policlinico Giaccone
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
State/Province
PD
Country
Italy
Facility Name
Ospedale Civile
City
Polla
State/Province
SA
Country
Italy
Facility Name
Divisione di Oncologia Medica, U.S.L.L. 13
City
Noale
State/Province
VE
ZIP/Postal Code
30033
Country
Italy
Facility Name
Ospedale L. Sacco
City
Milano
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Monaldi
City
Napoli
Country
Italy
Facility Name
Azienda Sanitaria Locale 2
City
Pozzuoli
Country
Italy
Facility Name
Istituto Regina Elena, Divisione di Oncologia Medica
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
Ospedale San Camillo - Forlanini
City
Rome
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22031232
Citation
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.
Results Reference
result

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

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