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S0820, Adenoma and Second Primary Prevention Trial (PACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01349881
Recruitment Status : Recruiting
First Posted : May 9, 2011
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer Prevention Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE May 5, 2011
First Posted Date  ICMJE May 9, 2011
Last Update Posted Date August 8, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)		 3-year event rate after registration among Stage 0-III colon or rectal cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.) [ Time Frame: 3 years ]
The primary objective is to assess whether the combination of eflornithine 500 mg and sulindac 150 mg is effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in patients with previously treated Stage 0, I, II, and III colon or rectal cancer.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2011)		 3-year event rate after registration among Stage 0-III colon cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.) [ Time Frame: 3 years ]
The primary objective is to assess whether elfornithine 500 mg or sulindac 150 mg 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.
Change History Complete list of historical versions of study NCT01349881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Incidence of colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events or total colorectal events at 3 years. [ Time Frame: 3 years and 8 years ]
    Incidence of colorectal lesions with respect to high grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events (defined as the number of patients with at least one high risk adenoma, 2nd primary colorectal cancer, colorectal cancer recurrence, or metastasis) or total colorectal cancer events (defined as the number of patients with at least one advanced colorectal event or polyp)at 3 years and 8 years.
  • Toxicity by CTCAEv.4.0 at 3 years [ Time Frame: 3 years ]
    Quantitative and qualitative toxicities at 3 years.
  • Examine interaction of treatment arm and genotype expression with respect to different outcomes. [ Time Frame: 3 years and 8 years ]
  • Interaction of intervention arm and baseline statin use with respect to 3-year event rate. [ Time Frame: 3 year ]
    Interaction of intervention arm and baseline statin use with respect to 3-year event rate will be examined.
  • Evaluate SNPs associated with decreased adenoma/second primary CRC risk and AEs [ Time Frame: 3 years and 8 years ]
    Evaluate a minimal set of tagging single nucleotide polymorphisms across multiple genes relevant to eflornithine and sulindac, in order to characterize associations with decreased adenoma/second primary CRC risk and adverse events.
  • Interaction of the intervention arm and patient-reported meat consumption with respect to the 3-year event rate [ Time Frame: 3 year ]
    To explore the interaction of the intervention arm and patient-reported meat consumption with respect to the 3-year event rate.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
  • Incidence of colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events or total colorectal events at 3 years. [ Time Frame: 3 years and 8 years ]
    Incidence of colorectal lesions with respect to high grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events (defined as the number of patients with at least one high risk adenoma, 2nd primary colorectal cancer, colorectal cancer recurrence, or metastasis) or total colorectal cancer events (defined as the number of pateints with at least one advanced colorectal event or polyp)at 3 years and 8 years.
  • Toxicity by CTCAEv.4.0 at 3 years [ Time Frame: 3 years ]
    Quantitative and qualitative toxicities at 3 years.
  • Examine interaction of treatment arm and genotype expression with respect to different outcomes. [ Time Frame: 3 years and 8 years ]
  • Interaction of intervention arm and baseline statin use with respect to 3-year event rate. [ Time Frame: 3 year ]
    Interaction of intervention arm and baseline statin use with respect to 3-year event rate will be examined.
  • Evaluate SNPs associated with decreased adenoma/second primary CRC risk and AEs [ Time Frame: 3 years and 8 years ]
    Evaluate a minimal set of tagging single nucleotide polymorphisms across multiple genes relevant to eflornithine and sulindac, in order to characterize associations with decreased adenoma/second primary CRC risk and adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S0820, Adenoma and Second Primary Prevention Trial
Official Title  ICMJE 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)
Brief Summary 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 through III colon or rectal cancer.
Detailed Description The purpose of this study is to assess whether the combination of eflornithine 500 mg and sulindac 150 mg (compared to corresponding placebos) has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas >/= 0.3 cm, total advanced colorectal events, or total colorectal events.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: Eflornithine placebo & sulindac placebo
    Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years
  • Drug: eflornithine & sulindac placebo
    Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.
  • Drug: Eflornithine placebo & sulindac
    Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
  • Drug: Eflornithine plus sulindac
    Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
Study Arms  ICMJE
  • Placebo Comparator: eflornithine placebo & sulindac placebo
    Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.
    Intervention: Drug: Eflornithine placebo & sulindac placebo
  • Experimental: Eflornithine & sulindac placebo
    Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one tablet PO daily for 3 years.
    Intervention: Drug: eflornithine & sulindac placebo
  • Experimental: Eflornithine placebo & sulindac
    Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
    Intervention: Drug: Eflornithine placebo & sulindac
  • Experimental: Eflornithine plus sulindac
    Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
    Intervention: Drug: Eflornithine plus sulindac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2011)		 1340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2029
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
  • At least 30 days from completion of adjuvant chemo and RT.
  • Presence of gastroesophageal reflux disease acceptable if controlled with medications

  • Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis. NSAID use must not exceed 10 days per month; Maximum aspirin dose

    • 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.
  • Able to swallow oral medications
  • Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. (A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥ 3.4 x 1000/mcL for non-Hispanic black females. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
  • Zubrod PS 0-1, 18 years of age or older
  • Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
  • Offered opportunity to participate in blood specimen banking

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
  • Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
  • Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
  • ≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
  • Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
  • Significant medical or psychiatric condition that would preclude study completion (8 years)
  • No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
  • Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patricia N. O'Kane, B.S. 210-614-8808 ext 1011 pokane@swog.org
Contact: Dana Sparks, MAT 210-614-8808 ext 1004 dsparks@swog.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01349881
Other Study ID Numbers  ICMJE S0820
U10CA037429 ( U.S. NIH Grant/Contract )
NCI-2012-02067 ( Other Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Cancer Prevention Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Jason A. Zell, D.O., MPH University of California, Irvine
PRS Account Southwest Oncology Group
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP