Colorectal Cancer NRG GI-002

April 11, 2017

Sponsor: National Cancer Institute (NCI)

Number: NRG GI-002

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety) trial studies how well Veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started, to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs used, such as modified (m) FOLFOX6 regimen, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving Veliparib with combination chemotherapy and radiation therapy may kill more tumor cells. Giving it before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Who’s eligible:

• The patient must have a diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact.
• The tumor must be clinically determined to be locally advanced stage II or stage III rectal cancer, defined as meeting any ONE of the following criteria:
  • Distal location: cT3-4 =< 5 cm from the anal verge/anus, any N (as defined by measurement on magnetic resonance imaging [MRI], transrectal ultrasound [ERUS]/pelvic computed tomography [CT] (with IV contrast) scan, or palpable on digital rectal examination [DRE]).
  • Bulky: any cT4 with the majority of the untreated tumor < 12 cm from the anal verge/anus  or below the peritoneal reflection as determined by the treating surgeon. Also, evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan.
  • High risk for metastatic disease with 4 or more regional lymph nodes (cN2).
  • Not a candidate for sphincter-sparing surgical resection, prior to neoadjuvant therapy (as planned by the primary surgeon).

• This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center, Backus Hospital- Eastern Connecticut Hematology and Oncology, and Hartford Hospital.