NCI Community Oncology Research Program - Protocol Summary
SWOG S0820 - "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)".
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: GI
RESEARCH BASE: SWOG S0820
NCT NUMBER: 01349881
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Colorectal, prior Stg 0-III w/resection alone or in combination with radiation or chemotherapy, NED, Placebo-controlled Eflornithine & Sulindac to prevent high-risk adenoma & 2nd prim recurrence. DCP-001 Eligible
THIS TRIAL IS DCP-001 ELIGIBLE
Treatment Plan (Supplied Drugs: Eflornithine, Sulindac & placebos)
BASELINE ASMT (180-456 days post resection)
Colonoscopy, Audiogram, CEA (>T3 or N+), CT or MRI (high-risk pts; investigator's discretion), Blood (optional)
Eflornithine/placebo: 2 tablets daily for 3 years AND
Sulindac/placebo: 1 tablet daily for 3 years
Final Colonoscopy (3 yrs post-randomiz), Audiogram, CEA (>T3 or N+)
FOLLOW-UP (annually x 5 yrs after 3 yrs of intervention)
- Prior Stg 0-III colon or rectal adenocarcinoma treated w/resection alone or in combination with radiation or chemo (no polypectomy or EMR). Adjuv chemo and RT completed >30 days pre-regist.
- Patients must be registered between 180 days and 456 days (inclusive) of primary resection. Patients must show no evidence of disease (NED) based on post-operative colonoscopy (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration) and CT scans* of chest, abdomen and pelvis (performed at least
180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration). Patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed. (*CT scan is for high risk patients, as per NCCN guidelines and at the discretion of the treating physician.)
- Age >18.
- No cardiovascular risk factors including uncontrolled high BP (systolic >150 mmHg), unstable angina, prior documented MI or CVA, NYHA Class III-IV heart failure, or known uncontrolled hyperlipidemia w/i last 3 yrs (LDL-C ≥190 mg/dL or triglycerides ≥500 mg/dL).
- No known hx of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease.
- Must have pure tone audiometry eval (by audiologist) to document air conduction w/i 30 days pre-regist. No >40dB hearing loss in any of 5 tested frequencies (250, 500, 1,000, 2,000, or 4,000 Hz). Test only after any ear infection has resolved. Conduct in hearing test room & insert earphones. NOTE: Don't order audiometry eval until pt has met all other criteria.
- No known hypersensitivity to either study agent or excipient byproducts. No prior allergic reactions to aspirin or other NSAIDs.
- No prior gastric/duodenal ulcer w/i last 12 mos, not currently on tx for such, or experiencing symptoms at study entry. GERD is allowed & pts may take OTC tx.
- Zubrod 0-1.
- Not expecting to receive RT or additional chemo.
- No current or plans to receive concomitant corticosteroids, NSAIDs, or anticoagulants on a regular or predictable intermittent basis. NSAID use <10 days/mo. Cardiovascular prophylaxis allowed if ASA <100mg/day or < two 325mg tabs/wk.
- Must be offered participation in specimen submission for banking for translational medicine studies.
- Must be offered participation in Diet/Lifestyle substudy.
- Able to swallow PO meds.
- No significant medical/psychiatric condition to preclude study completion. Tests/Exams for such <28 days pre-regist.
- Within 28 days pre-regist: Total WBC >40,000/mcL; platelets >100,000/mcL; Hgb >11.0g/dL; serum bili <2.0mg/dL; SGOT or SGPT <2x IULN; serum creat <1.5x IULN.
- No prior malignancy (other than Bullet 1), except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancer disease-free >5 yrs.
- No pregnant or nursing women. Women/Men of reproductive potential must use effective contraception.
- Not currently participating in another clinical trial for tx or prevention of cancer unless they are no longer receiving the intervention for that trial. Must not join another such trial while on SWOG S0820.
- PRE-STUDY REQUIREMENTS:
- H&P, wt, perf status, no significant medical/psychiatric condition to preclude study completion
- Audiometry eval (don't order until all other eligibility criteria have been met)
- CBC, WBC, platelets, Hgb, serum bili, SGOT/SGPT, serum creat
- CEA (only if >T3 or N+ tumors)
- Colonoscopy (>274 days after resection & prior to regist)
- CT chest/abdomen/pelvis (>180 days after resection & prior to regist)
- Blood specimen for nutritional assays & banking (optional)
- Diet/Lifestyle Questionnaire (optional)
- Signed informed consent.