Skip Navigation Links
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES) S-0820
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES) S-0820
 
Region Sponsors
Mid-Atlantic
Southwest Oncology Group (SWOG)
 
Acronym KP IRB No.
PACES MA-15-110
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Colorectal Cancer Stages 0-III Survivors; 1 year > colorectal surgery; At least 30 days from completion of adjuvant chemotherapy and Radiation Therapy;
 
Purpose
The primary objective of the PACES Study is to assess whether daily eflornithine 500 mg (oral dose) or daily sulindac 150 mg (oral dose) are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in Stage 0, I, II, and III colon cancer patients.
 
Detailed Description
The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0-lll (An event is defined as high-risk adenoma or second primary colorectal cancer.)
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
  • Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
  • Not receiving or planning to receive concomitant corticosteroids,nonsteroidal anti-inflammatory drugs(NSAIDs), nor anticoagulants. Maximum aspirin dose 100 mg per day or <= two 325 mg tablets per week.
  • Able to swallow oral medications.
  • Laboratory: WBC >= 4.0 x 103/mcL, platelets >= 100,000/mcL and hemoglobin > 11.0 g/dL. Serum bilirubin <= 2.0 mg/dL and AST (SGOT) or ALT(SGPT) <= 2 x IULN. Serum creatinine <= 1.5 x
  • Must not have cardiovascular risk factors including: unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
  • Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >= 190 mg/dL or triglycerides >= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
 
Exclusion Criteria
  • History of colon resection > 40 cm
  • Mid-low rectal cancer
  • Recurrent or metastatic disease
  • High cardiovascular risk, Uncontrolled hypertension
  • Planned radiation therapy or additional chemotherapy

 
Keywords and/or Specific Medical Conditions
  • Eflornithine/sulindac Prevention Trial
  • Stage 0-III Colorectal Cancer (CRC) Survivors
  • Colorectal neoplasms
  • Oncology (Adult)
  • CRC Recurrence Prevention
  • Preventative Medicine
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)
  • Preventative Medicine


Principal Investigator:
Leon C Hwang, MD
Contact Information:
- Diane Fisher, RN
-301-386-6692
-Diane.Fisher@kp.org
-Largo Medical Center


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!





Regional Research Sites: