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Two Chemotherapy Regimens Plus or Minus Bevacizumab (BETTER 2)

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ClinicalTrials.gov Identifier: NCT03351296
Recruitment Status : Not yet recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: LV5FU2 Drug: Streptozocin Drug: Capecitabine Drug: Temozolomide Drug: Bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative phase II trial with two randomizations
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Experimental: LV5FU2 + streptozotocin +/- Bevacizumab Drug: 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)

Drug: Streptozocin
streptozotocin 800 mg/m² day 1 every 14 days

Drug: Bevacizumab
bevacizumab 5 mg/kg every 14 days

Experimental: Capecitabine + temozolomide +/- Bevacizumab Drug: Capecitabine
Capecitabine 750 mg/m² twice daily, days 1-14

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

Drug: Bevacizumab
bevacizumab 5 mg/kg every 14 days




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Until disease progression or unacceptable toxicity (median 24 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Well differentiated pancreatic neuroendocrine tumor grade 1 (NET G1) or grade 2 (NET G2): mitotic index<20 and Ki67 index<20 %
  2. Indication for chemotherapy for locally advanced or metastatic disease with proven progression (at least 20% increase of tumor size on a maximum 12 months period of follow-up) or other indication of chemotherapy following the National Thesaurus of GI Cancerology (Appendix 6) (liver involvement > 50%, symptoms related to the tumour or its metastases, Ki67>10%) (Appendix 6)
  3. Patient with at least one measurable target tumor by RECIST 1.1 that thas never been irradiated
  4. Patient with a life expectancy greater than 3 months
  5. Men or women with performance status (ECOG) ≤ 2
  6. Age ≥ 18 years
  7. Adequate hematological function: neutrophil count (ANC) ≥ 2x109/L, platelets >/= 75x109/L, hemoglobin >/= 10g/dl (blood transfusions are accepted to reach this level).
  8. Adequate liver function: serum bilirubin </= 3 x upper limit of normal (ULN); aminotransferases and alkaline phosphatase levels </= 2.5 ULN (</= 5 ULN if liver metastases), TP > 50%
  9. Proteinuria ≤ 1g/24 h, blood creatinine less than 120 μmol/L and creatinin clearance ≥ 60 ml/min as calculated by Cockroft-Gault formula
  10. Absence of active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding
  11. Prior treatment with somatostatin analogues, everolimus or sunitinib is allowed
  12. Negative serum pregnancy test ≤ 72 hours before randomization (for women of childbearing potential only). Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for at least 6 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 6 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
  13. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  14. Patient affiliated to a social security regimen or beneficiary of such regimen

Exclusion Criteria:

  1. Disease accessible to resection or percutaneous method of destruction
  2. Any known allergy or contraindication to the treatments used in the trial, and in particular known DPD deficiency.
  3. Patient previously treated with chemotherapy for the neuroendocrine tumour
  4. Patient have received any other antitumor therapy: chemotherapy, immunotherapy
  5. 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.
  6. Subjects with a history of chronic or acute hepatitis C or B infection.
  7. Surgery during the 5 weeks preceding the randomization
  8. 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.
  9. Neurological or psychiatric pathology that may interfere with adherence to treatment
  10. Patients have received yellow fever vaccine within 30 days prior to the first dose of trial treatment.
  11. Patient with pernicious anaemia and other megaloblastic anaemias secondary to the lack of Vitamin B12
  12. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
  13. Hypersensitivity to study drugs or any of its excipients
  14. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
  15. Pregnant or breast feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351296


Contacts
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Contact: Michel Ducreux, MD, PhD 0142116017 ext +33 michel.ducreux@gustaveroussy.fr
Contact: Dune Lemettre 0142116643 ext +33 dune.lemettre@gustaveroussy.fr

Locations
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France
Gustave Roussy Not yet recruiting
Villejuif, Val De Marne, France, 94805
Contact: Michel Ducreux, MD, PhD    0142116017 ext +33    michel.ducreux@gustaveroussy.fr   
Contact: Dune Lemettre    0142116643 ext +33    dune.lemettre@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03351296     History of Changes
Other Study ID Numbers: 2017-000741-46
2017/2523 ( Other Identifier: CSET number )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bevacizumab
Capecitabine
Temozolomide
Streptozocin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antibiotics, Antineoplastic