Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers: the ARMANI Phase III Trial

NCT02934464 Phase 3 UNKNOWN

This is a randomized, open-label, multicenter phase III trial of ramucirumab plus paclitaxel, given as switch maintenance, versus continuation of first-line chemotherapy, given as per standard clinical practice, in subjects with unresectable locally advanced or metastatic HER-2 negative gastric or GEJ cancer, without disease progression following 3 months of first-line doublet chemotherapy. The acceptable first-line or lead-in chemotherapy will be: * FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days. * ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days. * XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

Details

Lead sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase	Phase 3
Status	UNKNOWN
Enrolment	280
Start date	2016-12
Completion	2021-12

Conditions

• Stomach Neoplasms

Interventions

• RAMUCIRUMAB
• Paclitaxel
• FOLFOX 4
• mFOLFOX 6
• XELOX

Primary outcomes

• Progression-Free Survival (PFS) — 3 years
  Progression-Free Survival (PFS)

Countries

Italy