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Sponsored by: |
University Hospital, Brest |
Information provided by: | University Hospital, Brest |
ClinicalTrials.gov Identifier: | NCT00744900 |
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile.
The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.
The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.
Condition | Intervention | Phase |
Lung Cancer |
Drug: Pemetrexed, cisplatin |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Cisplatin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Pemetrexed disodium Pemetrexed Folic acid Vitamin B 12 Hydroxocobalamin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL). |
Estimated Enrollment: | 45 |
Study Start Date: | August 2008 |
Arms | Assigned Interventions |
A: Experimental |
Drug: Pemetrexed, cisplatin
Alimta 500mg/m² IV 10 min infusion and Cisplatin 75mg/m² IV 60 min on day 1. Cycle will be repeated each 21 days.Folic acid orally 400µg should begin 5-7days prior to the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. Vitamin B12 will be administered as a 1000 mg intramuscular injection, approximately one week before Day 1 of cycle 1 and should repeat approximately every 9 weeks Dexamethasone, 4 mg or equivalent, should be taken orally twice per day on the day before, the day of, and the day after each dose of pemetrexed.WBRT will be administered with high energy photons systematically after cycle 6 or in case of stable disease (SD) after cycle 4 or progressive disease (PD) at any time. The dose will be 3Gy by fraction, 1 fraction per day, for 10 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
CHU brest, institut de cancérologie et d'hématologie | |||||
Brest, France, 29200 | |||||
CH GAP | |||||
GAP, France, 05000 | |||||
Institut de Cancérologie de la Loire | |||||
Saint-Priest en Jarez Cedex, France, 42271 | |||||
Hopital de la Croix Rousse | |||||
LYON, France, 69317 | |||||
Hôpital Sainte Margueritte | |||||
MARSEILLES, France, 13274 | |||||
Pneumologie, Centre hôspitalier, DRAGUIGNAN | |||||
DRAGUIGNAN, France, 83300 | |||||
Pneumologie, Centre Hospitalier | |||||
VILLEFRANCHE sur SAONE, France, 69655 | |||||
Centre Hôspitalier du Pays d'Aix, Service des Maladies Respiratoires | |||||
AIX EN PROVENCE, France, 13616 | |||||
Médecine 4, C.H.G. de la Fontonne Antibes | |||||
ANTIBES, France, 06606 | |||||
CHU de ROUEN, Hôpital Bois Guillaume, Serv. de Pneumo. | |||||
Rouen, France, 76233 | |||||
Luc THIBERVILLE | |||||
ROUEN, France, 76031 | |||||
Hôpital Pontchailloux, Service de Pneumologie. | |||||
RENNES, France, 35033 | |||||
Centre Hospitalier René Dubos - Pontoise, Service d'Oncologie - Hématologie Clinique | |||||
CERGY PONTOISE, France, 95303 | |||||
Serv. de Pneumo - Hôpital St Antoine | |||||
Paris, France, 75571 | |||||
Serv. de Pneumo-Allergo, CH de Martigues | |||||
MARTIGUES, France, 13695 | |||||
Service Pneumologie, Pavillon 1A, CH de Lyon-Sud | |||||
PIERRE-BENITE, France, 69495 | |||||
Centre Hospitalier, Service de Pneumologie | |||||
Charleville, France, 08 000 | |||||
CHU d'Angers, Service de Pneumologie | |||||
Angers, France, 49033 | |||||
CHI, Service de Pneumologie | |||||
CRETEIL, France, 94010 | |||||
CHG, Service de Pneumologie | |||||
ROANNE, France, 42300 | |||||
CHU, Service du Pr. Carles | |||||
TOULOUSE, France, 31059 | |||||
Hôpital A. Mignot, Service de Pneumologie | |||||
LE CHESNAY, France, 78157 | |||||
Centre François Baclesse | |||||
Caen, France, 14000 | |||||
Centre Hospitalier Départemental, Service de Pneumologie, | |||||
LA ROCHE SUR YON, France, 85000 | |||||
Centre Hôspitalier, Service de Pneumo-Neuro | |||||
MANTES LA JOLIE, France, 78200 |
University Hospital, Brest |
Principal Investigator: | Gilles Robinet, MD | CHU Brest |
Principal Investigator: | Barlesi Barlesi, MD, Ph.D | Assistance Publique Hôpitaux de Marseille |
Principal Investigator: | Isabelle Monet, MD | Centre Hospitalier, Créteil |
Responsible Party: | CHU BREST, Institut de Cancerologie et d'Hématologie ( Gilles ROBINET/MD ) |
Study ID Numbers: | GFPC 07-01, RB 07.103 |
First Received: | August 29, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00744900 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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