Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2018-06-26
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LV5FU2 + streptozotocin
LV5FU2
LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)
Streptozocin
streptozotocin 800 mg/m² day 1 every 14 days
Capecitabine + temozolomide
Capecitabine
Capecitabine 750 mg/m² twice daily, days 1-14
Temozolomide
temozolomide 200 mg/m² once daily, days 10-14, every 28 days
LV5FU2 + streptozotocin + Bevacizumab
LV5FU2
LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)
Streptozocin
streptozotocin 800 mg/m² day 1 every 14 days
Bevacizumab
bevacizumab 5 mg/kg every 14 days
Capecitabine + temozolomide + Bevacizumab
Capecitabine
Capecitabine 750 mg/m² twice daily, days 1-14
Temozolomide
temozolomide 200 mg/m² once daily, days 10-14, every 28 days
Bevacizumab
bevacizumab 5 mg/kg every 14 days
Interventions
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LV5FU2
LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)
Streptozocin
streptozotocin 800 mg/m² day 1 every 14 days
Capecitabine
Capecitabine 750 mg/m² twice daily, days 1-14
Temozolomide
temozolomide 200 mg/m² once daily, days 10-14, every 28 days
Bevacizumab
bevacizumab 5 mg/kg every 14 days
Eligibility Criteria
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Inclusion Criteria
2. Any known allergy or contraindication to the treatments used in the trial
3. Patients with a complete DPD deficiency; defined as an uracil concentration ≥150ng/ml Note: patients with a suspicion of partial DPD deficiency, defined as a uracil concentration ≥ 16 ng/ml and \< 150 ng/ml, will receive an adapted 1st cycle dose, according to a clinic-biological discussion. The dose can be then readapted for the second cycle according to the tolerability of the treatment during the 1st cycle.
4. Patient previously treated with chemotherapy for the neuroendocrine tumour
5. Patient have received any other antitumor therapy: chemotherapy, immunotherapy
6. Other serious diseases such as respiratory failure or congestive heart failure, angina pectoris not medically controlled; history of myocardial infarction within 6 months prior to study entry, uncontrolled hypertension and arrhythmias, concomitant severe infection or uncontrolled diabetes mellitus
7. Subjects with a history of chronic or acute hepatitis C or B infection.
8. Surgery during the 5 weeks preceding the randomization
9. History of cancer (except basal cell skin or carcinoma in situ carcinoma of the cervix) within 5 years prior to entry into the trial. But patients with cancers that have been treated more than 5 years ago and are considered as cured are eligible.
10. Neurological or psychiatric pathology that may interfere with adherence to treatment
11. Patients have received yellow fever vaccine within 30 days prior to the first dose of trial treatment.
12. Patient with pernicious anaemia and other megaloblastic anaemias secondary to the lack of Vitamin B12
13. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
14. Hypersensitivity to study drugs or any of its excipients
15. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
16. Pregnant or breast feeding women
18 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Centre Antoine Lacassagne
Nice, Alpes-Maritimes, France
CHU de Caen
Caen, Calvados, France
CHU de Dijon
Dijon, Côte d'Or, France
Hôpital Haut-Lévêque
Pessac, Gironde, France
IUCT - Hôpital Rangueil
Toulouse, Haute-Garonne, France
Hôpital Beaujon
Clichy, Hauts-de-Seine, France
ICM Val d'Aurelle
Montpellier, Hérault, France
Hôpital Trousseau CHU Tours
Chambray-lès-Tours, Indre-et-Loire, France
Institut de Cancérologie de l'Ouest site René Gauducheau
Saint-Herblain, Loire-Atlantique, France
CHR d'Orléans
Orléans, Loiret, France
CHU Angers
Angers, Maine-et-Loire, France
Hôpital Haut-Lévêque
Reims, Marne, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Hôpital Edouard Herriot
Lyon, Rhône, France
Gustave Roussy
Villejuif, Val De Marne, France
Hôpital Croix St Simon
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Centre Eugène Marquis
Rennes, Île-et-Vilaine, France
Countries
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Other Identifiers
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2017/2523
Identifier Type: OTHER
Identifier Source: secondary_id
2017-000741-46
Identifier Type: -
Identifier Source: org_study_id
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