NCI ID NCI-2012-02067
NCT ID NCT01349881
CTEP ID S0820
Primary Purpose PREVENTION
Anatomic Sites Multiple
Minimum Age 18 Years
Maximum Age 999 Years
Gender BOTH
Lead Org SWOG
Principal Investigator Jason Adam Zell
NCI Site View on ClinicalTrials.gov

Eflornithine and/or Sulindac in Preventing Recurrence of High-Risk Adenomas and Second Primary Disease in Patients with Stage 0-III Colon or Rectal Cancer

This phase III trial studies how well eflornithine works compared to sulindac in preventing the return of the disease (recurrence) of high-risk adenomas and second primary disease in patients with stage 0-III colon or rectal cancer. Drugs used in chemotherapy, such as eflornithine and sulindac, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility

Inclusion Criterea

  • STEP 0: REGISTRATION (Optional)
  • Patients with a primary colon or rectal cancer resection who are potentially eligible for S0820 may be pre-registered at Step 0; patients registered to Step 0 will appear on an institutional patient tracking report; patients registered to Step 0 are not registered to the S0820 protocol; to participate in S0820, patients must be registered to Step 1 after patient is consented and evaluation of eligibility; patients registered to S0820 at Step 0 continuing to Step 1 registration must use the same Southwest Oncology Group (SWOG) patient identification (ID) for registration to S0820 Step 1
  • STEP 1: REGISTRATION
  • Patients must have a history of stage 0, I, II or III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy; adjuvant chemotherapy and radiation therapy (RT) treatment must have been completed at least 30 days prior to registration
  • Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection); the definition of resection does not include endomucosal resection (EMR); patients that have received total proctocolectomy are ineligible * In addition to segmental resections, the following types of procedures are allowed: ** Polypectomy: for Tis (stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met: *** Single specimen, completely removed *** Negative margins of resection *** Grade 1 or 2 *** No angiolymphatic invasion ** Transanal local excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if National Comprehensive Cancer Network (NCCN) criteria for transanal excision are met, as stipulated here: *** NCCN Criteria for transanal excision: **** < 3 cm in size **** T1 **** Grade 1 or 2 **** No lymphatic or venous invasion **** Negative margin **** Sm3 depth of tumor invasion is not allowed ** When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used; TEM for more proximal lesions may be technically feasible
  • Patients must be registered between 120 days and 456 days (inclusive) of primary resection; patients must show no evidence of colorectal cancer based on post-operative colonoscopy (performed at least 120 days after the colon or 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
  • Patients must be at least 18 years of age
  • Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration; patients with hearing loss > 40 decibels (dB) in any of the five tested frequencies (250 Hertz [Hz], 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz) are not eligible; patients with active ear infections should be tested only after the acute phase of infection has resolved; for optimal results, it is recommended that testing be conducted by an audiologist, in a hearing test room, with insert earphones * Note: Sites should not order audiometry evaluation until the potential participant has met all other eligibility criteria required for this study
  • Patients must have a Zubrod performance status of 0-1
  • Patients must have the ability to swallow oral medication
  • Total white blood cells (WBC) >= 4.0 x 10^3/mcL (within 28 days prior to registration)
  • Platelets >= 100,000/mcL (within 28 days prior to registration)
  • Hemoglobin > 11.0 g/dL (within 28 days prior to registration)
  • A total WBC >= 3.1 x 10^3/mcL is allowed for non-Hispanic black males (NHBM) and total WBC >= 3.4 x 10^3/mcL for non-Hispanic black females (NHBF) * Exception: If the WBC is lower than the above levels, the patient may be enrolled IF the absolute neutrophil count (ANC) is >= 1.3 for NHBM, >= 1.4 for NHBF, or >= 1.5 for all
  • Serum bilirubin =< 2.0 mg/dL (within 28 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x IULN (institutional upper limit of normal) (within 28 days prior to registration)
  • Serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration
  • Patients with a prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen, are eligible for this trial
  • SPECIMEN SUBMISSION AND SUBSTUDY CRITERIA
  • Patients must be offered the option to participate in submission of specimens for banking for future translational medicine studies
  • Patients participating through PK sites, must be offered the option to submit blood specimens for population pharmacokinetic analysis
  • Patients must be offered the option to participate in the Diet and Lifestyle Substudy
  • REGULATORY CRITERIA
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion Criterea

  • Patients must not have cardiovascular risk factors including unstable angina, history of documented myocardial infarction or cerebrovascular accident, coronary artery bypass surgery, or New York Heart Association class III or IV heart failure; patients must not have known uncontrolled hyperlipidemia (defined as fasting low-density lipoprotein cholesterol [LDL-C] >= 190 mg/dL or triglycerides >= 500 mg/dL) within the last 3 years prior to registration or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
  • Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, inflammatory bowel disease, biallelic mismatch repair deficiency syndrome (BMMRD), or constitutional mismatch repair deficiency syndrome (CMMRD)
  • Patients must not have known hypersensitivity to eflornithine or sulindac or the excipients byproducts; patients must not have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal antiinflammatory drug (NSAID)
  • Patients must not have documented history of gastric/duodenal ulcer within the last 12 months; participant must not currently be on treatment for gastric/duodenal ulcer or be experiencing symptoms at study entry; patients with gastroesophageal reflux disease (GERD) are eligible, however, and these patients may receive over-the-counter histamine-2 (H2) antagonists; proton-pump inhibitors, or other prescription-based treatment for GERD
  • Patients must not be expecting to receive radiation or additional chemotherapy
  • Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis; (NSAID use may not exceed 10 days per month); patients may receive daily aspirin for cardiovascular prophylaxis as long as acetylsalicylic acid (ASA) is =< 100 mg per day or =< two 325 mg tablets per week; inhaled steroids (i.e. for asthma or related conditions) are allowed
  • Patients must have no significant medical or psychiatric condition that would preclude study completion; tests and exams for this determination should be completed within 28 days prior to registration
  • Patients must not be pregnant or nursing (due to the status of eflornithine and sulindac as pregnancy class C agents); women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Individuals must not currently be participating in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only; patients must also agree not to join such a trial while participating in this study

Participating Clinics

Cancer and Blood Specialists-Henderson


2460 West Horizon Ridge Parkway
Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Las Vegas Cancer Center-Medical Center


6450 Medical Center Street
Las Vegas, NV 89148-2405
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson


1505 Wigwam Parkway
Suite 130 Henderson, NV 89074
Map

702-384-0013
research@sncrf.org

Las Vegas Cancer Center-Henderson


2904 West Horizon Ridge Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Henderson


52 North Pecos Road
Henderson, NV 89074
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Las Vegas


3006 South Maryland Parkway
Suite 100 Las Vegas, NV 89109
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Tenaya


2851 North Tenaya Way
Suite 101 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson


10001 South Eastern Avenue
Suite 108 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest


7445 Peak Drive
Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central


624 South Tonopah Drive
Las Vegas, NV 89106
Map

702-384-0013
research@sncrf.org

Cancer Therapy and Integrative Medicine


3340 Topaz Street
Suite 100 Las Vegas, NV 89121
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada


9280 West Sunset Road
Suite 100 Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley


3730 South Eastern Avenue
Las Vegas, NV 89169
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway


3006 South Maryland Parkway
Suite 205 Las Vegas, NV 89109
Map

702-384-0013
research@sncrf.org

University Medical Center of Southern Nevada


1800 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast


3980 South Eastern Avenue
Las Vegas, NV 89119
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Fort Apache


6160 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Vegas Tenaya


2851 North Tenaya Way
Suite 100 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Cancer and Blood Specialists-Shadow


701 Shadow Lane
Suite 300 Las Vegas, NV 89106
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache


6190 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-San Martin


8285 West Arby Avenue
Suite 100 Las Vegas, NV 89113
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills


6850 North Durango Drive
Suite 120 Las Vegas, NV 89149
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin


655 North Town Center Drive
Las Vegas, NV 89144
Map

702-384-0013
research@sncrf.org

Cancer and Blood Specialists-Tenaya


3150 North Tenaya Way
Suite 430 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills


3175 Saint Rose Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston


2300 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013

OptumCare Cancer Care at MountainView


3150 North Tenaya Way
Suite 510 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge


2460 West Horizon Ridge Parkway
Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Lake Huron Medical Center


2601 Electric Avenue
Port Huron, MI 48060
Map

702-384-0013
research@sncrf.org

Valley Medical Center


400 South 43rd Street
Renton, WA 98055
Map

425-228-3440
research@valleymed.org