Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Collaborator: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Paclitaxel; Ramucirumab

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