A Phase I Study of veliparib (ABT-888) in combination with low-dose fractionated whole abdominal radiation therapy (LDFWAR) in patients with advanced solid malignancies with peritoneal carcinomatosis with two additional dose levels in patients with epithelial ovarian, fallopian or primary peritoneal cancers and intra-abdominal disease.
This research study is being done to determine if the investigational drug ABT-888 (veliparib)in combination with low dose whole abdominal radiation given in divided doses, is generally safe, tolerable and effective in people with advanced solid tumor cancer who also have peritoneal carcinomatosis(cancer cells/spread of disease within the lining of the abdomen).
Adult patients (18 & older) with solid tumor that is refractory to standard treatments available and metastatic or unresectable who also have peritoneal carcinomatosis(cancer cells/spread of disease within the lining of the abdomen). Normal kidney and liver function, as well as adequate blood counts are required. No prior abdominal radiation. If there was prior pelvic radiation there can be no overlap of the previous and current planned fields of treatment. No current, know brain metastasis. Prior treated brain metastasis allowed if proven stable with no recurrence/relapse in prior 3 months. No treatment of any kind (radiation, surgery, chemotherapy or clinical trial) in prior 4 weeks. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. No evidence of documented malignant bowel obstruction. No clinical evidence of bleeding. No pregnant women. No HIV positive patients. No uncontrolled ascites or history of seizures. No prior PARP inhibitor therapy. No disease outside of the planned abdominal radiation fields. Must be able and willing to swallow capsules. No allergy or hypersensitivity to component formulation.
ABT-888 capsules will be taken every day for 21 consecutive days of a 28 day cycle. (3 weeks on drug/ 1 week break). The low dose whole abdominal radiation will be given in a divided BID dose twice weekly during the 3 weeks the patient is taking the ABT-888. (generally Monday and Friday.) Patient must be seen for labs and physical exam once a week during the 3 weeks of therapy. Total therapy will be 3 months. Patients will then be followed every 2 months with CT scans.
07/23/2014 04:02 AM