MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
This study is currently recruiting participants.
Verified January 2013 by National Cancer Institute, Naples
Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01405586
First received: February 26, 2010
Last updated: January 15, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Stage IIIB |
Drug: Gemcitabine Drug: Cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute, Naples:
Primary Outcome Measures:
- overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- worst grade toxicity per patient [ Time Frame: at end of each 3 week cycle of chemotherapy ] [ Designated as safety issue: Yes ]worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
- progression free survival [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: baseline and 8, 21, 29, and 42 days after therapy initiated ] [ Designated as safety issue: No ]
- objective response [ Time Frame: after 9 and 18 weeks of therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 480 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: gemcitabine |
Drug: Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
|
| Experimental: gemcitabine + cisplatin |
Drug: Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
- Stage III B or Stage IV disease
- Age > or = 70 years
- ECOG Performance status 0 or 1
- Patient at first diagnosis or with recurrence after primary surgery
- At least one target or non-target lesion according to RECIST criteria
- Life expectancy of at least 3 months
- Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 10g/dl
- Creatinine < 1.5 x the upper normal limit
- AST and ALT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)
- Bilirubin < 1.5 x the upper normal limit
- Signed informed consent
Exclusion Criteria:
- Previous chemotherapy for advanced disease
- History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- Symptomatic cerebral or spinal cord metastasis
- Myocardial infarct within the last 12 months
- Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
- Known or suspected hypersensitivity to any of the drugs used in the study
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405586
Contacts
| Contact: Francesco Perrone, M.D., Ph.D. | +39 081 5903571 | francesco.perrone@usc-intnapoli.net |
| Contact: Massimo Di Maio, M.D. | +39 081 5903383 | massimo.dimaio@usc-intnapoli.net |
Locations
| Italy | |
| Ospedale Villa Scassi | Recruiting |
| Genova, GE, Italy, 16100 | |
| Policlinico Giaccone | Recruiting |
| Palermo, PA, Italy, 90127 | |
| Azienda Ospedaliera Universitaria Senese | Recruiting |
| Siena, SI, Italy, 53100 | |
| Ospedale San Lazzaro | Recruiting |
| Alba, Italy | |
| Ospedale Regina Apostolorum | Recruiting |
| Albano Laziale, Italy | |
| S. Giuseppe Moscati | Recruiting |
| Avellino, Italy | |
| Ospedale Senatore Antonio Perrino | Recruiting |
| Brindisi, Italy | |
| Ospedale A. Cardarelli | Recruiting |
| Campobasso, Italy | |
| Ospedale Ramazzini di Carpi | Recruiting |
| Carpi, Italy | |
| Ospedale Civile di Faenza | Recruiting |
| Faenza, Italy | |
| A.O. Vito Fazzi-Lorusso | Recruiting |
| Lecce, Italy | |
| Istituto Sceintifico Romagnolo | Recruiting |
| Meldola, Italy | |
| Ospedale L. Sacco Polo Universitario | Recruiting |
| Milano, Italy | |
| U.L.S.S. 13 | Recruiting |
| Mirano, Italy | |
| Azienda Ospedaliera Cardarelli | Recruiting |
| Napoli, Italy, 80131 | |
| Second University of Naples | Recruiting |
| Napoli, Italy, 80131 | |
| A.O. Università Federico II | Recruiting |
| Napoli, Italy | |
| Istituto Nazionale dei Tumori | Recruiting |
| Napoli, Italy | |
| Istituto Oncologico Veneto | Recruiting |
| Padova, Italy | |
| Ospedale Guglielmo d Saliceto-Piacenza | Recruiting |
| Piacenza, Italy | |
| Ospedale S. Maria delle Croci | Recruiting |
| Ravenna, Italy | |
| Ospedale Umberto I | Recruiting |
| Ravenna, Italy | |
| A.O. S. Camillo Forlanini | Recruiting |
| Roma, Italy | |
| IRCCS Casa Sollievo Sofferenza | Recruiting |
| S. Giovanni Rotondo, Italy | |
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
| Principal Investigator: | Cesare Gridelli, M.D. | S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology |
| Principal Investigator: | Francesco Perrone, M.D., Ph.D | National Cancer Institute Naples, Italy; Director Clinical Trials Unit |
| Principal Investigator: | Ciro Gallo, M.D., Ph.D | Second University of Naples, Italy; Chair of Medical Statistics |
More Information
No publications provided
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT01405586 History of Changes |
| Other Study ID Numbers: | MILES-3, 2009-013540-36 |
| Study First Received: | February 26, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by National Cancer Institute, Naples:
|
elderly chemotherapy |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms Neoplasms, Second Primary Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013