NCT02934464

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	RAMUCIRUMAB
DRUG	Paclitaxel	Paclitaxel
DRUG	FOLFOX 4
DRUG	mFOLFOX 6
DRUG	XELOX

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2016-10-17
• Last updated: 2021-09-13

Locations

1 site across 1 country: Italy