Two Chemotherapy Regimens Plus or Minus Bevacizumab

NCT03351296 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2017-000741-462017/2523
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 20

Brief Summary

Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in combination with bevacizumab (beva) on progression-free survival (PFS) and compare the chemotherapy regimens alone or with beva (two by two design) on the same criteria.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) rate

  Until disease progression or unacceptable toxicity (median 24 months)

Secondary Outcomes (1)

• Toxicity (NCI-CTCAE 4.0)

  Until disease progression or unacceptable toxicity

Study Arms (4)

LV5FU2 + streptozotocin

EXPERIMENTAL

Drug: LV5FU2; Drug: Streptozocin

Capecitabine + temozolomide

EXPERIMENTAL

Drug: Capecitabine; Drug: Temozolomide

LV5FU2 + streptozotocin + Bevacizumab

EXPERIMENTAL

Drug: LV5FU2; Drug: Streptozocin; Drug: Bevacizumab

Capecitabine + temozolomide + Bevacizumab

EXPERIMENTAL

Drug: Capecitabine; Drug: Temozolomide; Drug: Bevacizumab

Interventions

LV5FU2 DRUG

LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)

LV5FU2 + streptozotocin; LV5FU2 + streptozotocin + Bevacizumab

Streptozocin DRUG

streptozotocin 800 mg/m² day 1 every 14 days

LV5FU2 + streptozotocin; LV5FU2 + streptozotocin + Bevacizumab

Capecitabine DRUG

Capecitabine 750 mg/m² twice daily, days 1-14

Capecitabine + temozolomide; Capecitabine + temozolomide + Bevacizumab

Temozolomide DRUG

temozolomide 200 mg/m² once daily, days 10-14, every 28 days

Capecitabine + temozolomide; Capecitabine + temozolomide + Bevacizumab

Bevacizumab DRUG

bevacizumab 5 mg/kg every 14 days

Capecitabine + temozolomide + Bevacizumab; LV5FU2 + streptozotocin + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease accessible to resection or percutaneous method of destruction
• Any known allergy or contraindication to the treatments used in the trial
• 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.
• Patient previously treated with chemotherapy for the neuroendocrine tumour
• Patient have received any other antitumor therapy: chemotherapy, immunotherapy
• 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
• Subjects with a history of chronic or acute hepatitis C or B infection.
• Surgery during the 5 weeks preceding the randomization
• 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.
• Neurological or psychiatric pathology that may interfere with adherence to treatment
• Patients have received yellow fever vaccine within 30 days prior to the first dose of trial treatment.
• Patient with pernicious anaemia and other megaloblastic anaemias secondary to the lack of Vitamin B12
• Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
• Hypersensitivity to study drugs or any of its excipients
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• National Cancer Institute, France: collaborator

Study Sites (20)

Centre Antoine Lacassagne

Nice, Alpes-Maritimes, 06189, France

Location

CHU de Caen

Caen, Calvados, 14033, France

Location

CHU de Dijon

Dijon, Côte d'Or, 21000, France

Location

Hôpital Haut-Lévêque

Pessac, Gironde, 33600, France

Location

IUCT - Hôpital Rangueil

Toulouse, Haute-Garonne, 31400, France

Location

Hôpital Beaujon

Clichy, Hauts-de-Seine, 92110, France

Location

ICM Val d'Aurelle

Montpellier, Hérault, 34298, France

Location

Hôpital Trousseau CHU Tours

Chambray-lès-Tours, Indre-et-Loire, 37170, France

Location

Institut de Cancérologie de l'Ouest site René Gauducheau

Saint-Herblain, Loire-Atlantique, 44800, France

Location

CHR d'Orléans

Orléans, Loiret, 45067, France

Location

CHU Angers

Angers, Maine-et-Loire, 49100, France

Location

Hôpital Haut-Lévêque

Reims, Marne, 51092, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519, France

Location

Hôpital Edouard Herriot

Lyon, Rhône, 69437, France

Location

Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

Hôpital Croix St Simon

Paris, 75012, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Centre Eugène Marquis

Rennes, Île-et-Vilaine, 35000, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Streptozocin; Capecitabine; Temozolomide; Bevacizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dacarbazine; Triazenes; Imidazoles; Azoles; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative phase II trial with two randomizations

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: June 26, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

FR (20)