Status:
ACTIVE_NOT_RECRUITING
Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Stomach Cancer
Stomach Neoplasm
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03760822
Start Date
November 16 2018
End Date
December 1 2024
Last Update
July 8 2024
Active Locations (38)
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1
CH -
Abbeville, France
2
CH - Albi
Albi, France
3
PRIVEE - L'Europe
Amiens, France
4
CAC - ICO Site Paul Papin
Angers, France