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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00401609
First received: November 17, 2006
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: gemcitabine
Drug: vinorelbine
Drug: cisplatin
Drug: etoposide
Drug: carboplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

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

Estimated Enrollment: 85
Study Start Date: November 2000
Study Completion Date: February 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401609

Locations
Italy
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
Ospedale La ferla
Palermo, PA, Italy
Policlinico Giaccone
Palermo, PA, Italy
Policlinico Universitario P. Giaccone
Palermo, PA, Italy, 90100
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
Ospedale Monaldi
Napoli, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
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
Investigators
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
  More Information

No publications provided

Responsible Party: Francesco Perrone, NCI Naples
ClinicalTrials.gov Identifier: NCT00401609     History of Changes
Other Study ID Numbers: G-Step
Study First Received: November 17, 2006
Last Updated: February 3, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
elderly

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014