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

NCT03760822 | Active Not Recruiting Phase 2

• 1 other identifier: PRODIGE 55 - SOCRATE
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 38

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

Keywords

ramucirumab; elderly patient; second line therapy

Outcome Measures

Primary Outcomes (4)

• Patient survival rate at 6 months

  Rate of patients alive

  at 6 months

• Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility

  Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.

  at 4 months

• Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future

  Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.

  at 4 months

• Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden

  Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score

  at 4 months

Secondary Outcomes (3)

• Overall survival

  6 months

• Time to treatment failure

  6 months

• Progression-free survival

  6 months

Study Arms (2)

Ramucirumab

EXPERIMENTAL

IV ramucirumab at 8 mg/kg on D1 and D15

Drug: Ramucirumab

Ramucirumab + Paclitaxel

ACTIVE COMPARATOR

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

Drug: Ramucirumab; Drug: Paclitaxel

Interventions

Ramucirumab DRUG

IV ramucirumab at 8 mg/kg on D1 and D15

Also known as: Cyramza

Ramucirumab; Ramucirumab + Paclitaxel

Paclitaxel DRUG

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

Also known as: Abraxane

Ramucirumab + Paclitaxel

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead
• Eli Lilly and Company: collaborator

Study Sites (38)

CH -

Abbeville, France

Location

CH - Albi

Albi, France

Location

PRIVEE - L'Europe

Amiens, France

Location

CAC - ICO Site Paul Papin

Angers, France

Location

Privee - Hopital Prive

Antony, France

Location

Ch - Victor Dupouy

Argenteuil, France

Location

Ch - Metz Thionville Mercy

Ars-Laquenexy, France

Location

Ch - Ght Unyon Auxerre

Auxerre, France

Location

Privee - Institut Du Cancer Avignon Provence

Avignon, France

Location

Ch - Cote Basque

Bayonne, France

Location

Ch - Beauvais Ch

Beauvais, France

Location

Chu - Jean Minjoz

Besançon, France

Location

Privee - Tivoli

Bordeaux, France

Location

PRIVEE - Polyclinique Saint Privat

Boujan-sur-Libron, France

Location

Ch - Duchenne

Boulogne-sur-Mer, France

Location

Ch - Pierre Oudot

Bourgoin, France

Location

Privee - Pasteur Lanroze

Brest, France

Location

Cac - François Baclesse

Caen, France

Location

Chu - Côte de Nacre

Caen, France

Location

Ch - Jean Rougier

Cahors, France

Location

Privee - Infirmerie Protestante

Caluire-et-Cuire, France

Location

CH -

Carcassonne, France

Location

Ch - Castres Mazamet Chi

Castres, France

Location

Prive - Médipole de Savoie

Challes-les-Eaux, France

Location

Prive - Sainte Marie

Chalon-sur-Saône, France

Location

CH -

Cholet, France

Location

Ch - Hopitaux Civils de Colmar

Colmar, France

Location

Hopitaux civils de Colmar

Colmar, France

Location

Chu - Louis Mourier

Colombes, France

Location

Prive - Saint Côme

Compiègne, France

Location

Prive - Cédres

Cornebarrieu, France

Location

Chu - Henri Mondor

Créteil, France

Location

Prive - Centre Leonard de Vinci

Dechy, France

Location

Cac - Gf Leclerc

Dijon, France

Location

Chu - Francois Mitterrand

Dijon, France

Location

CH -

Dunkirk, France

Location

CHI - Elbeuf Louviers Val de Reuil

Elbeuf, France

Location

Clinique privée - CENTRE CARIO

Plérin, France

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Ramucirumab; Paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins

Study Officials

• Astrid Lièvre, Pr

  CHU de Pontchaillou - Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: November 30, 2018
• Study Start: November 16, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

FR (38)