MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer
- Conditions
- Non-small Cell Lung Cancer MetastaticNon-small Cell Lung Cancer Stage IIIB
- Interventions
- Registration Number
- NCT01656551
- Lead Sponsor
- National Cancer Institute, Naples
- Brief Summary
The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 232
- Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
- Non squamous tumor type (including those with a non-specified tumor type).
- Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
- Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
- At least one target or non-target lesion according to RECIST revised version 1.1.
- Male or female > or = 70 years of age.
- ECOG PS 0 or 1.
- Life expectancy > 3 months.
- Neutrophils > or = 1500 mm3, platelets > or = 100000 mm3, and haemoglobin > or = 9 g/dL.
- Bilirubin level either normal or < 1.5 x ULN.
- AST (SGOT) and ALT (SGPT) < or = 2.5 x ULN (< or = 5 x ULN if liver metastasis are present).
- Serum creatinine < 1.5 x ULN.
- Signed written informed consent.
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.
- Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
- Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed).
- Known or suspected hypersensitivity to any of the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description B: Gemcitabine + Cisplatin Gemcitabine Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks B: Gemcitabine + Cisplatin Cisplatin Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks C: Pemetrexed Pemetrexed - A: Gemcitabine Gemcitabine Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks D: Pemetrexed + Cisplatin Cisplatin - D: Pemetrexed + Cisplatin Pemetrexed -
- Primary Outcome Measures
Name Time Method overall survival one year factorial design with two comparisons: single agent chemotherapy versus chemotherapy plus cisplatin (Arms A+C versus Arms B + D), and gemcitabine versus pemetrexed (Arms A+B versus Arms C+D)
- Secondary Outcome Measures
Name Time Method objective response after 9 and 18 weeks of therapy changes in quality of life baseline and up to 18 weeks worst grade toxicity per patient evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks according to Common Toxicity Criteria for Adverse Events v. 4.03
progression free survival 6 months
Trial Locations
- Locations (48)
Ospedale della Madonna della Navicella
🇮🇹Chioggia, Italy
Ospedale Fabrizio Spaziani
🇮🇹Frosinone, Italy
IRCCS AOU San Martino IST Genova
🇮🇹Genova, Italy
Ospedale L. Sacco Polo Universitario
🇮🇹Milano, Italy
U.L.S.S. 13
🇮🇹Mirano, Italy
H San Gerardo
🇮🇹Monza, Italy
Istituto Nazionale dei Tumori
🇮🇹Napoli, Italy
Casa di cura La Maddalena
🇮🇹Palermo, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Irccs - Crob
🇮🇹Rionero in Vulture, Italy
Oncologia IRCCS - Casa Sollievo Sofferenza
🇮🇹San Giovanni Rotondo, Italy
AO San Camillo Forlanini
🇮🇹Roma, Italy
A.O. di Busto Arsizio
🇮🇹Saronno, Italy
Ospedale S. Andrea
🇮🇹Vercelli, Italy
Ospedale A. cardarelli
🇮🇹Campobasso, Italy
Ospedale Ramazzini di Carpi
🇮🇹Carpi, Italy
Azienda Ospedaliera Garibalda Nesimadi Catania
🇮🇹Catania, Italy
Ospedale Villa Scassi
🇮🇹Genova, Italy
Ospedale Umberto I
🇮🇹Lugo, Italy
A.O.U. Federico II
🇮🇹Napoli, Italy
Ospedale Cardirelli
🇮🇹Napoli, Italy
Seconda Università di Napoli
🇮🇹Napoli, Italy
Ospedale SS. TrinitÃ
🇮🇹Sora, Italy
Ospedale Cardinal Massaia
🇮🇹Asti, Italy
S. Giuseppe Moscati
🇮🇹Avellino, Italy
U.L.S.S. 15 Veneto
🇮🇹Camposampiero, Italy
Policlinico vittorio Emanuele
🇮🇹Catania, Italy
Ospedale Civile di Faenza
🇮🇹Faenza, Italy
Ospedale Civile di Legnano
🇮🇹Legnano, Italy
Ospedale S. Paolo
🇮🇹Milano, Italy
Azienda Ospedaliera Vito Fazzi
🇮🇹Lecce, Italy
IRCCS-Meldola
🇮🇹Meldola, Italy
Ospedale S. Giovanni Calibita Fatebenfratelli
🇮🇹Roma, Italy
Ospedale Guglielmo da Saliceto-USL di Piacenza
🇮🇹Saliceto, Italy
ASL Viterbo Ospedale Belcolle
🇮🇹Viterbo, Italy
Istituto Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Ospedale Civile Umberto I
🇮🇹Pagani, Italy
Azienda Ospedaleira Ospedali Riuniti Villa Sofia Cervello
🇮🇹Palermo, Italy
Ospedale di Sondrio
🇮🇹Sondrio, Italy
Ospedale S. Bortolo
🇮🇹Vicenza, Italy
Campus Biomedico
🇮🇹Roma, Italy
A.O. San Carlo
🇮🇹Potenza, Italy
Ospedali Riunit Umberto I-Lancisi-Salesi
🇮🇹Ancona, Italy
Oncologia Universitaria degli Studi di Roma
🇮🇹Aprilia, Italy
Ospedale San Lazzaro
🇮🇹Alba, Italy
Univeristaria Policlinico Monserrato di Cagliari
🇮🇹Cagliari, Italy
Ospedale Senatore Antonio Perrino
🇮🇹Brindisi, Italy