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 — ARMANI  

Stomach Neoplasms Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Treatment must be continued for up to 4 three-weekly cycles or 6 bi-weekly cycles, or for up to a maximum of 12 weeks. Subjects with CR/PR/SD after oxaliplatinum compound and fluoropyrimidine-based regimens, or without evidence of progressive disease in case of non-measurable disease, will be randomized in 1:1 ratio between the two treatment arms.

Prior to randomization, subjects will be stratified based on Center; Prior gastrectomy: No vs. Yes; Peritoneal carcinomatosis: Yes vs. No; Site of origin: GEJ vs. gastric. ;

Related Conditions & MeSH terms

• Stomach Neoplasms

• NCT number: NCT02934464
• Study type: Interventional
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: MARIA DI BARTOLOMEO, MD
• Phone: +390223902882
• Email: maria.dibartolomeo@istitutotumori.mi.it
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2016
• Completion date: December 2021