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S0820, Adenoma and Second Primary Prevention Trial (PACES)

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ClinicalTrials.gov Identifier: NCT01349881
Recruitment Status : Recruiting
First Posted : May 9, 2011
Last Update Posted : December 21, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer Prevention Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Eflornithine placebo & sulindac placebo Drug: eflornithine & sulindac placebo Drug: Eflornithine placebo & sulindac Drug: Eflornithine plus sulindac Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1340 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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)
Study Start Date : March 2013
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2029

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: eflornithine placebo & sulindac placebo
Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.
 Drug: Eflornithine placebo & sulindac placebo
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years
Experimental: Eflornithine & sulindac placebo
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one 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.
Experimental: Eflornithine placebo & sulindac
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg 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.
Experimental: Eflornithine plus sulindac
Eflornithine two 250 mg 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Toxicity by CTCAEv.4.0 at 3 years [ Time Frame: 3 years ]
    Quantitative and qualitative toxicities at 3 years.

  3. Examine interaction of treatment arm and genotype expression with respect to different outcomes. [ Time Frame: 3 years and 8 years ]
  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349881


Contacts
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

  Show 947 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Cancer Prevention Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jason A. Zell, D.O., MPH University of California, Irvine
More Information
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01349881     History of Changes
Other Study ID Numbers: S0820
U10CA037429 ( U.S. NIH Grant/Contract )
NCI-2012-02067 ( Other Identifier: NCI )
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

Keywords provided by Southwest Oncology Group:
Eflornithine/sulindac prevention trial

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Sulindac
 Eflornithine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypanocidal Agents
Antiprotozoal Agents