Clinical Trials Logo

Clinical Trial Summary

This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France. Main eligibility criteria include: histologically proven adenocarcinoma of the stomach, esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.


Clinical Trial Description

Patients are randomised to modified FOLFOX6 (oxaliplatin 85 mg/m2, FA 400 mg/m², FU 400 mg/m² bolus then 2400 mg/m² over 46 hr) alone or combined to either panitumumab (6 mg/kg) or AMG 102 (10 mg/kg), every two weeks until unacceptable toxicity or disease progression. Judgment criteria include 4-month progression-free survival (PFS) rate (primary endpoint), OS, objective response rate, and safety. Ancillary studies aim to identify candidate predictive and prognostic biomarkers among functional of molecular alterations of the EGFR/RAS/RAF and HGF/c-Met pathways, and to monitor circulating tumour cells and circulating immune cells (myeloid derived suppressor cells, NK cells) in sequential blood samples taken at baseline and through the study treatment. A total of 165 pts will be enrolled (Fleming's one-step design) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01443065
Study type Interventional
Source UNICANCER
Contact
Status Completed
Phase Phase 2
Start date January 2011
Completion date September 2018

See also
  Status Clinical Trial Phase
Terminated NCT01727908 - Screening for Familial Gastric Cancer in First Degree Relatives N/A
Completed NCT02337673 - Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography
Completed NCT02158988 - Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis Phase 3
Recruiting NCT01642953 - Early Recovery After Gastric Cancer Surgery Phase 2
Active, not recruiting NCT02205047 - Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2
Recruiting NCT02381847 - Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Phase 3
Completed NCT01758965 - Surgicel® Fibrillar for Delayed Bleeding After ESD N/A
Completed NCT02528110 - Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer Phase 2
Completed NCT01187212 - Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE Phase 2
Recruiting NCT05880667 - Adaptive Radiation for Abdominopelvic Metastases Phase 1
Recruiting NCT04345770 - Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer Phase 2