second-line chemotherapy with ramucirumab +/- paclitaxel in elderly advanced gastric or gastroesophageal junction cancer patients

Conditions: Stomach Cancer; Stomach Neoplasm; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Summary: the primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or gej adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed. the co-primary endpoints are the following: * six months survival rate * quality of life at 4 months as assessed by the following three target dimensions of the eortc qlq-eld14 questionnaire: mobility, illness burden and worries about the future


Eligibility criteria:
inclusion criteria: * histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma, whatever her2 status * aged ≥ 70 years * who \< 2 * estimated life expectancy \> 3 months * measurable or non-measurable disease according to recist 1.1 criteria * documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed) * adequate hepatic, renal and hematologic function: * anc ≥ 1 500 / mm3, platelets ≥ 100 000 / mm3, hemoglobin ≥ 9 g/dl * blood creatinine ≤ 1.5 x uln and creatinine clearance (mdrd formula) ≥ 40 ml/min * total bilirubin ≤ 1.5 x uln, ast and alt ≤ 3 x uln (≤ 5 x uln if hepatic metastasis) * inr ≤ 1.5 or inr ≤ 3 for patients taking avk and ptt ≤ 5 seconds above the uln * dipstick proteinuria ≤ 1+ or 24 hour proteinuria \< 1 g in total * eortc qlq-c30 + qlq-eld14, completed and faxed to the randomization, management and analysis center of the ffcd * iadl geriatric questionnaire, completed and faxed to randomization management and analysis center of ffcd * signed informed consent exclusion criteria: * known cerebral metastasis * prior treatment by taxanes * prior treatment with an antiangiogenic * neuropathy of grade ≥ 2 (nci-ctcae 4.0) * unresolved partial or total bowel obstruction, inflammatory bowel disease (such as crohn's disease or ulcerative colitis) or extensive gastrointestinal (gi) resection combined with chronic diarrhea * gi perforation and/or fistulae in the 6 months preceding randomization. * gi bleeding within the last 3 months of grade ≥ 3 (nci-ctcae 4.0) * chronic use of antiplatelet drugs (including aspirin, but a daily intake of ≤ 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents * any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization * a life-threatening episode of pulmonary embolism in the 6 months preceding randomization * deep-vein thrombosis, pulmonary embolism (pe), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant" during the 3 months prior to first dose of protocol therapy * uncompensated congestive heart failure or uncontrolled arrhythmia * uncontrolled hypertension (≥ 140/90 mm hg for \> 4 weeks) despite properly observed antihypertensive therapy * cirrhosis at a level of chilg-pugh b or c; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization * radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy * known allergy to paclitaxel or ramucirumab * another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated * lack of effective contraception in patients (man and/or women) of childbearing age, and/or their * persons deprived of liberty or under supervision * impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Keywords: ramucirumab elderly patient second line therapy