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

NCT ID: NCT03760822

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2024-12-31

Brief 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ramucirumab

IV ramucirumab at 8 mg/kg on D1 and D15

Group Type: EXPERIMENTAL

Ramucirumab

Intervention Type: DRUG

IV ramucirumab at 8 mg/kg on D1 and D15

Ramucirumab + Paclitaxel

IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15

Group Type: ACTIVE_COMPARATOR

Ramucirumab

Intervention Type: DRUG

IV ramucirumab at 8 mg/kg on D1 and D15

Paclitaxel

Intervention Type: DRUG

IV paclitaxel at 80 mg/m² on D1, D8 and D15

Interventions

Ramucirumab

IV ramucirumab at 8 mg/kg on D1 and D15

Intervention Type: DRUG

Paclitaxel

IV paclitaxel at 80 mg/m² on D1, D8 and D15

Intervention Type: DRUG

Other Intervention Names

Cyramza; Abraxane

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid Lièvre, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU de Pontchaillou - Rennes

Locations

CH -

Abbeville, , France

CH - Albi

Albi, , France

PRIVEE - L'Europe

Amiens, , France

CAC - ICO Site Paul Papin

Angers, , France

Privee - Hopital Prive

Antony, , France

Ch - Victor Dupouy

Argenteuil, , France

Ch - Metz Thionville Mercy

Ars-Laquenexy, , France

Ch - Ght Unyon Auxerre

Auxerre, , France

Privee - Institut Du Cancer Avignon Provence

Avignon, , France

Ch - Cote Basque

Bayonne, , France

Ch - Beauvais Ch

Beauvais, , France

Chu - Jean Minjoz

Besançon, , France

Privee - Tivoli

Bordeaux, , France

PRIVEE - Polyclinique Saint Privat

Boujan-sur-Libron, , France

Ch - Duchenne

Boulogne-sur-Mer, , France

Ch - Pierre Oudot

Bourgoin, , France

Privee - Pasteur Lanroze

Brest, , France

Cac - François Baclesse

Caen, , France

Chu - Côte de Nacre

Caen, , France

Ch - Jean Rougier

Cahors, , France

Privee - Infirmerie Protestante

Caluire-et-Cuire, , France

CH -

Carcassonne, , France

Ch - Castres Mazamet Chi

Castres, , France

Prive - Médipole de Savoie

Challes-les-Eaux, , France

Prive - Sainte Marie

Chalon-sur-Saône, , France

CH -

Cholet, , France

Ch - Hopitaux Civils de Colmar

Colmar, , France

Hopitaux civils de Colmar

Colmar, , France

Chu - Louis Mourier

Colombes, , France

Prive - Saint Côme

Compiègne, , France

Prive - Cédres

Cornebarrieu, , France

Chu - Henri Mondor

Créteil, , France

Prive - Centre Leonard de Vinci

Dechy, , France

Cac - Gf Leclerc

Dijon, , France

Chu - Francois Mitterrand

Dijon, , France

CH -

Dunkirk, , France

CHI - Elbeuf Louviers Val de Reuil

Elbeuf, , France

Clinique privée - CENTRE CARIO

Plérin, , France

Countries

France

Other Identifiers

PRODIGE 55 - SOCRATE

Identifier Type: -

Identifier Source: org_study_id