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

Investigating the Effects of Adding Investigational Medication to Chemotherapy for Prostate Cancer (PCA)

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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.

Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: pancreatic cancer
  • Age: 18 years - 100 years
  • Gender: All

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

Updated on 19 Feb 2024. Study ID: 1611317566

This study investigates the effects of adding an investigational medication to the usual chemotherapy regimen for patients with prostate cancer (PCA). Prostate cancer is a disease where cancer cells form in the tissues of the prostate. The study aims to understand the positive or negative effects of this combination treatment on the participants.

Participants will be randomly assigned to different study arms. Some will receive the investigational medication along with their regular chemotherapy, while others may receive a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. This helps researchers compare the effects of the investigational medicine to those of the standard treatment.

  • Who can participate: Adults with a diagnosis of prostate cancer with metastatic or recurrent disease can participate. They must have a life expectancy greater than 12 weeks and adequate organ function.
  • Study details: Participants will be assigned to receive either the investigational medication with chemotherapy or a placebo. The placebo is an inactive substance that resembles the investigational medication but has no therapeutic effect. Participants will not be compensated for their involvement in the study.

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