Status:
TERMINATED
Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Colorectal Cancer
Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: \- Some types of inflammation may increase the risk of cancers in the intestinal track. Because of this possibility, anti-inflammatory drugs may be able to prevent tumor growth and spread...
Detailed Description
* Despite strong evidence for a causative role of inflammatory mediators in intestinal cancer, the underlying mechanisms remain obscure. Established evidence indicates activation of the Wnt/beta-caten...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Histologically confirmed colorectal adenocarcinoma with metastatic disease confined to the liver, or limited extrahepatic intra-abdominal disease Note: limited sites of disease include:
- porta hepatis lymph node metastases
- pelvic lymph node metastases (internal iliac, external iliac or obturator)
- Hepatic and intra-abdominal metastases must be measurable by computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan
- Liver disease must be amenable to gross total resection (R0/R1) with adequate functional liver remnant which requires preservation of at least 2 contiguous hepatic segments with adequate inflow, outflow, and biliary drainage with a functional liver remnant (FLR) volume of more than 20% (for healthy liver)
- Greater than or equal to 18 years of age.
- Must be able to understand and sign the Informed Consent Documentation.
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2.
- Life expectancy of greater than six months.
- Patients of both genders must be willing to practice birth control during and for one week after taking sulindac/placebo.
- Hematology:
- Absolute neutrophil count greater than 1500/mm\^3 without the support of Filgrastim.
- Platelet count greater than 75,000/mm\^3.
- Hemoglobin greater than 8.0 g/dl.
- Chemistry:
- Serum creatinine less than or equal to 1.5 mg/dl unless the measured creatinine clearance is greater than 60mL/min/1.73m\^2.
- Total bilirubin less than or equal to 2 mg/dl, except for patients with diagnosis of Gilberts disease or hepatic pedicle obstruction then total bilirubin must be less than or equal to 5 mg/dl.
- International normalized ratio (INR) less than or equal to 1.8.
- INCLUSION CRITERIA for NORMAL VOLUNTEERS
- Age greater than 18
- Able to read and understand the informed consent
- No self-reported co morbidities of history of cancer
- EXCLUSION CRITERIA
- Women of child-bearing potential who are pregnant or breast feeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
- Active systemic infections, coagulation disorders or other major medical illnesses precluding major surgery.
- Patients receiving warfarin anticoagulation, who cannot be transferred to other agents, such as low molecular weight heparins, anti-factor Xa (anti-Xa) agents, etc.
- Active bleeding disorders
- Patients with uncontrolled hypertension (would suggest: systolic blood pressure (SBP)\> 155, diastolic blood pressure (DBP)\> 90), unstable coronary disease (unstable angina, evidence of congestive heart failure (CHF), or myocardial infarction (MI) within 6-12 months of study)
- Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies or with evidence of moderate to severe ascites.
- Prior history of gastrointestinal (GI) bleeding unrelated to a cancer diagnosis
- Note: Patients who have a normal upper and lower endoscopy may be enrolled at the discretion of the principal investigator (PI).
- Renal insufficiency Discretion of principle investigator.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01856322
Start Date
April 1 2013
End Date
January 1 2015
Last Update
October 23 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892