S0820, Adenoma and Second Primary Prevention Trial (PACES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Southwest Oncology Group
Sponsor:
Collaborators:
Cancer Prevention Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01349881
First received: May 5, 2011
Last updated: July 23, 2014
Last verified: July 2014

May 5, 2011
July 23, 2014
March 2013
July 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The primary objective is to assess whether eflornithine 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.
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01349881 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Interaction of intervention arm and baseline statin use with respect to 3-year event rate. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Interaction of intervention arm and baseline statin use with respect to 3-year event rate. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
S0820, Adenoma and Second Primary Prevention Trial
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 Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

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 cancer.

The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Colorectal Neoplasms
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1340
July 2019
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of Stage 0-III colon cancer with primary resection 1 year previously
  • Patients with rectosigmoid cancers eligible if no RT administered
  • One-year post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
  • Low risk or moderate risk of cardiovascular events
  • At least 30 days from completion of adjuvant chemo.
  • Presence of gastroesophageal reflux disease acceptable if controlled with medications
  • 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 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
  • ≥ 20 dB uncorrectable hearing loss for age of any two contiguous 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
Both
18 Years and older
No
Contact: Patricia N. O'Kane, B.S. 210-614-8808 ext 1011 pokane@swog.org
Contact: Kimberly J Farar, B.S. 210-614-8808 ext 1022 kfarar@swog.org
United States
 
NCT01349881
S0820, U10CA037429, NCI-2012-02067
Yes
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Cancer Prevention Pharmaceuticals, Inc.
Principal Investigator: Jason A. Zell, D.O., MPH University of California, Irvine
Southwest Oncology Group
July 2014

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