NRG-GI002

Clinical Trial Title Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
Trial Status Closed to Enrollment
Start Date 08/22/2018
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Rectal Cancer
Description This randomized phase II 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. Drugs used in chemotherapy, 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 and giving it before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Eligibility Criteria
  • Age ≥ 18 years at diagnosis
  • ECOG Performance Status of 0, 1, or 2
  • Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact
  • Locally advanced Stage II or Stage III rectal cancer

Ineligibility Criteria

  • Clinical or radiologic evidence of metastatic disease
  • Sensory or motor neuropathy ≥ grade 2
  • History of prior invasive rectal malignancy, regardless of disease-free interval
  •  Other invasive malignancy within 5 years before randomization.
  • Chemotherapy within 5 years before randomization
  • Active inflammatory bowel disease

Treatment

Group 1: Patients will receive neoadjuvant FOLFOX x 8 cycles (each cycle = 2 weeks) → chemoRT (plus capecitabine) → surgical resection 8-12 wks later.

Group 2: Patients will receive neoadjuvant FOLFOX x 8 cycles (each cycle = 2 weeks) → chemoRT (plus capecitabine + Veliparib) → surgical resection 8-12 wks later.
IRB Number NCI Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02921256
Principal Investigator Andrew Kee, MD
Contact Name Onoclogy Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-8199
Contact E-Mail 503-413-6920