Phase II Randomized Double-Blind Study of mFOLFIRINOX plus Ramucirumab versus mFOLFIRINOX plus placebo in Advanced Pancreatic Cancer Patients HCRN GI14-198

Overview

The purpose of this study is to find out what effects, good and/or bad, there are to adding the drug ramucirumab (RAM) to the usual chemotherapy regimen.

Description

The purpose of this study is to to find out what effects, good and/or bad, there are to adding the drug ramucirumab (RAM) to the usual chemotherapy regimen.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: pancreatic cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Male or Female

Inclusion Criteria
ECOG Performance Status fo 0-1 within 7 days prior to registration
Histologic or cytological diagnosis of PCA with radiological evidence of metastatic disease or recurrent disease
No prior first line systemic treatment
Measurable disease
Estimate life expectancy of >12weeks, as assessed by the site investigator
Demonstrate adequate organ function
If sexually active, must be postmenopausal, surgically sterile, or using effective contaception (hormonal or barrier methods) due to unknown risk of teratogenicity of ramucirumab
Exclusion Criteria
Ongoing or active infection
Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia
Uncontrolled or poorly-controlled hypertension despite standard medical management
Acute or sub-acute intestinal obstruction
Interstitial pneumonia or interstitial fibrosis of the lung, which in the opinion of the site investigator could compromise the subject or the study
Pleural effusion or ascities that causes > grade 1 dypsnea
Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis
Grade 3 or higher bleeding event less than or equal to 3 months prior to randomization
Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, less than or equal to 6 months prior to randomization
Documented and/or symptomatic or known brain or leptomeningeal metastases
Severely immune-compromised (other than being on steroids) including known HIV infection
Concurrent active malignancy, other than adequately treated nonmelanoma skin cancer, other noninvasive carcinoma, or in situ neoplasm
Breast-feeding or pregnant
Prior autologous or allogeneic organ or tissue transplantation
Known allergy to any of the treatment components
Major surgery within 28 days
Have any condition that does not permit compliance with the study schedule including psychological, geographical, or medical
Subcutaneous venous access device placement within 7 days prior to
enrollment
Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once daily aspirin use (maximum dose 325 mg/day) is permitted
Chronic non-healing wounds


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX7486

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