Two Chemotherapy Regimens Plus or Minus Bevacizumab

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT03351296
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)
  • Streptozocin — DRUG
    streptozotocin 800 mg/m² day 1 every 14 days
  • Capecitabine — DRUG
    Capecitabine 750 mg/m² twice daily, days 1-14
  • Temozolomide — DRUG
    temozolomide 200 mg/m² once daily, days 10-14, every 28 days
  • Bevacizumab — DRUG
    bevacizumab 5 mg/kg every 14 days

Study Details

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.

Key Dates

First listed
Nov 22, 2017
Start date
Jun 26, 2018
Status verified
May 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LV5FU2 + streptozotocin
  • Experimental: Capecitabine + temozolomide
  • Experimental: LV5FU2 + streptozotocin + Bevacizumab
  • Experimental: Capecitabine + temozolomide + Bevacizumab

Primary Outcome Measure

Progression Free Survival (PFS) rate [ Time Frame: Until disease progression or unacceptable toxicity (median 24 months) ]

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