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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401609
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : January 14, 2016
Information provided by:
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: gemcitabine Drug: vinorelbine Drug: cisplatin Drug: etoposide Drug: carboplatin Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2000
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gemcitabine
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401609

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Ospedale A. Cardarelli
Campobasso, CB, Italy, 86100
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, Italy, 87100
Ospedale Umberto di Frosinone
Frosinone, FR, Italy, 03031
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, Italy, 90100
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, Italy, 30033
Ospedale L. Sacco
Milano, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Ospedale Monaldi
Napoli, Italy
Azienda Sanitaria Locale 2
Pozzuoli, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, Italy, 00144
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Italy, 00186
Ospedale San Camillo - Forlanini
Rome, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Principal Investigator: Cesare Gridelli, M.D. San Giuseppe Moscati Hospital, Avellino, Italy
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute Naples, Italy

Publications of Results:
Responsible Party: Francesco Perrone, NCI Naples Identifier: NCT00401609     History of Changes
Other Study ID Numbers: G-Step
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by National Cancer Institute, Naples:

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors