PRODIGE 55-SOCRATE : A randomized phase II study to evaluate second-line ramucirumab alone or with paclitaxel in older patients with advanced gastric cancer

Prior treatment

• History of life-threatening pulmonary embolism in the 6 months prior to randomisation
• Serious or unhealed wound or peptic ulcer or fracture within 28 days prior to randomisation
• Radiotherapy or major surgery within 28 days prior to commencement of protocol treatment, or minor surgery/implantable chamber insertion within 7 days prior to commencement of protocol treatment.
• Lack of effective contraception in patients and/or their partners until at least 6 months after the end of treatment with paclitaxel.
• Previous treatment with taxanes
• Previous treatment with an antiangiogenic agent
• Digestive perforation and/or fistula in the 6 months prior to randomisation
• Chronic use of antiplatelet drugs, non-steroidal anti-inflammatory drugs, dipyridamole or clopidogrel or similar agents
• Any arterial thromboembolic event in the 6 months prior to randomisation.

Other illness

• Deep vein thrombosis or pulmonary embolism, or any other significant thrombosis in the 3 months preceding the start of protocol treatment
• Uncompensated congestive heart failure or uncontrolled arrhythmia
• Uncontrolled arterial hypertension despite properly observed antihypertensive treatment
• Known allergy to paclitaxel or ramucirumab
• Other concomitant cancer or history of cancer within 5 years,
• Unresolved intestinal obstruction or sub-occlusion or inflammatory bowel disease (Crohn's, ulcerative colitis, etc.) or extensive bowel resection associated with chronic diarrhoea.
• Grade ≥ 3 digestive bleeding less than 3 months old

Other

• Known brain metastasis
• Child-Pugh B or C cirrhosis, or cirrhosis resulting from cirrhosis.
• Person under guardianship, curatorship, safeguard of justice or person deprived of liberty
• Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.
• Neuropathy grade ≥ 2 (NCI-CTCAE 4.0)

• Histologically proven unresectable metastatic or locally advanced gastric or oesogastric junction adenocarcinoma, regardless of HER2 status
• Patient ≥ 70 years
• Estimated life expectancy > 3 months
• Measurable or non-measurable disease according to RECIST 1.1 criteria
• Documented progression on first-line chemotherapy or within 4 months of the last cycle of fluoropyrimidine- and platinum-salt-based or irinotecan-based (with or without anthracycline) chemotherapy for metastatic or locally advanced disease, or within 6 months of the last dose of fluoropyrimidine- and platinum-salt-based adjuvant therapy (immunotherapy is permitted).
• Adequate haematological, renal and hepatic function
• QLQ-C30 and QLQ-ELD-14
• Questionnaire gériatrique IADL
• Signed informed consent