GA NCORP

NCORP Trials

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

Status
Closed
Cancer Type
Colon/Rectal Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Prevention
NCD ID
NCT01349881
Protocol IDs
S0820 (primary)
U10CA037429
NCI-2012-02067
Study Sponsor
SWOG

Summary

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.

Objectives

PRIMARY OBJECTIVE:
I. To assess whether the combination of eflornithine and sulindac is effective in reducing the three-year event rate (high-risk adenomas and second primary colorectal cancers) in patients with previously treated stage 0-III colon or rectal cancer.

SECONDARY OBJECTIVES:
I. To assess whether the combination of eflornithine and sulindac (compared to corresponding placebos) has efficacy against the total colorectal event rate as a single aggregate event, defined as including high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas >= 0.3 cm, and total advanced colorectal events (e.g., high risk adenoma, 2nd primary colorectal cancer, colorectal cancer recurrence, or metastasis).
II. To assess adverse events after combination of eflornithine and sulindac intervention compared to corresponding placebos.

EXPLORATORY OBJECTIVES:
I. To explore the effect of the intervention on each component of the total colorectal event rate.
II. To assess the total colorectal event rate at 8 years after follow-up.
III. To evaluate biomarker responses of treatment effect using blood-based circulating tumor deoxyribonucleic acid (ctDNA) testing for minimal residual disease.
IV. To perform population pharmacokinetic (PK) analysis of eflornithine and sulindac in patients with previously treated stage 0-III colon or rectal cancer.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients receive eflornithine placebo orally (PO) once daily (QD) and sulindac placebo PO QD for 36 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive eflornithine PO QD and sulindac placebo PO QD for 36 months in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL PER PROTOCOL DATED 01/27/17)

ARM III: Patients receive eflornithine placebo PO QD and sulindac PO QD for 36 months in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL PER PROTOCOL DATED 01/27/17)

ARM IV: Patients receive eflornithine PO QD and sulindac PO QD for 36 months in the absence of disease progression or unacceptable toxicity.

Patients in all arms undergo colonoscopy and blood sample collection throughout the study.

After completion of study treatment, patients are followed up annually for 5 years.

Treatment Sites


Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
Trena Davis
770-219-8822
www.nghs.com

Study Coordinator:
Trena Davis BSN, RN, CRCC
770-219-8822

Doctors:

Andre M. Kallab MD
Richard J. LoCicero MD
Padma C. Nadella MD
Charles H. Nash, III MD, FACP
Geoffrey J. Weidner MD
Saloni H. Tanna MD
Christina A. Saurel MD

Piedmont Columbus Regional
1831 5th Ave
Columbus, GA 31901
www.columbusregional.com

Study Coordinator:
Jay Pitts, BS, CPhT
706-596-5426

Doctors:

Wilbur B. Bassett, Jr. MD
Andrew W. Pippas MD
Peter Q. Jiang MD
Suresh Nukala MD
 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org