Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
- Conditions
- Stomach NeoplasmGastric CancerGastroesophageal Junction AdenocarcinomaStomach Cancer
- Interventions
- Registration Number
- NCT03760822
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ramucirumab Ramucirumab IV ramucirumab at 8 mg/kg on D1 and D15 Ramucirumab + Paclitaxel Ramucirumab IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15 Ramucirumab + Paclitaxel Paclitaxel IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15
- Primary Outcome Measures
Name Time Method Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future at 4 months 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.
Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden at 4 months 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
Patient survival rate at 6 months at 6 months Rate of patients alive
Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility at 4 months 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.
- Secondary Outcome Measures
Name Time Method Time to treatment failure 6 months Time between randomization and disease progression, treatment interruption or death
Progression-free survival 6 months Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1
Overall survival 6 months Defined as time to death (whatever cause is) or for patients alive time to last news.
Trial Locations
- Locations (35)
CH - Albi
🇫🇷Albi, France
Privee - Hopital Prive
🇫🇷Antony, France
CH -
🇫🇷Dunkerque, France
Ch - Jean Rougier
🇫🇷Cahors, France
Ch - Metz Thionville Mercy
🇫🇷Ars-Laquenexy, France
Ch - Ght Unyon Auxerre
🇫🇷Auxerre, France
PRIVEE - L'Europe
🇫🇷Amiens, France
CAC - ICO Site Paul Papin
🇫🇷Angers, France
Ch - Victor Dupouy
🇫🇷Argenteuil, France
Privee - Institut Du Cancer Avignon Provence
🇫🇷Avignon, France
Ch - Cote Basque
🇫🇷Bayonne, France
Ch - Beauvais Ch
🇫🇷Beauvais, France
Privee - Tivoli
🇫🇷Bordeaux, France
Chu - Jean Minjoz
🇫🇷Besançon, France
PRIVEE - Polyclinique Saint Privat
🇫🇷Boujan-sur-Libron, France
Ch - Duchenne
🇫🇷Boulogne-sur-Mer, France
Ch - Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Ch - Hopitaux Civils de Colmar
🇫🇷Colmar, France
Prive - Saint Côme
🇫🇷Compiègne, France
Chu - Côte de Nacre
🇫🇷Caen, France
Privee - Pasteur Lanroze
🇫🇷Brest, France
Cac - François Baclesse
🇫🇷Caen, France
Privee - Infirmerie Protestante
🇫🇷Caluire-et-Cuire, France
Chu - Henri Mondor
🇫🇷Créteil, France
Prive - Médipole de Savoie
🇫🇷Challes-les-Eaux, France
Ch - Castres Mazamet Chi
🇫🇷Castres, France
Prive - Sainte Marie
🇫🇷Chalon-sur-Saône, France
Hopitaux civils de Colmar
🇫🇷Colmar, France
Prive - Cédres
🇫🇷Cornebarrieu, France
Chu - Louis Mourier
🇫🇷Colombes, France
Chu - Francois Mitterrand
🇫🇷Dijon, France
Prive - Centre Leonard de Vinci
🇫🇷Dechy, France
Cac - Gf Leclerc
🇫🇷Dijon, France
Clinique privée - CENTRE CARIO
🇫🇷Plérin, France
CHI - Elbeuf Louviers Val de Reuil
🇫🇷Elbeuf, France