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
Active
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 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.
II. To assess quantitative and qualitative toxicities of patients when treated with the combination of eflornithine and sulindac compared to corresponding placebos.
III. To 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 colorectal cancer (CRC) risk and adverse events.
IV. To evaluate biomarker responses of treatment effect using novel microfluidics-based digital droplet detection system.
V. To explore the interaction of intervention arm and baseline statin use with respect to the 3-year event rate.
VI. To explore the interaction of the intervention arm and patient-reported meat consumption with respect to the 3-year event rate.
VII. 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.

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

Treatment Sites