RO4929097 Before Surgery in Treating Patients With Pancreatic Cancer
Stopped early · Phase 1
Conditions studied: Adenocarcinoma of the Pancreas, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer
In brief
This phase I trial is studying the side effects of RO4929097 before surgery in treating patients with pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Giving RO4929097 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Key facts
- Study ID
- NCT01192763
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2010-08-01
- Last updated by the study team
- 2013-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- T1-3, N0-1, and M0 disease
- Surgically resectable disease confirmed by a surgeon experienced in pancreatic surgery
- No borderline resectable disease defined as any of the following:
- Tumors with severe unilateral or bilateral SMV/portal involvement impingement
- Abutment (or) encasement of hepatic artery
- SMA or celiac encasement (or) presence of SMV occlusion by tumor
- No metastatic disease
- ECOG performance status 0-1
- Life expectancy > 6 months
- WBC ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 2 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 2 mg/dL
- Calcium, magnesium, phosphorous, and potassium normal
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective barrier-method contraception 4 weeks before, during, and for ≥ 12 months after completion of treatment
- Able to swallow tablets
- No malabsorption syndrome or other condition that would interfere with intestinal absorption
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 or other agents used in the study
- No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia despite adequate electrolyte supplementation
Where it is running
- Tower Cancer Research Foundation — Beverly Hills, California, United States
- City of Hope Medical Center — Duarte, California, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- Illinois CancerCare-Peoria — Peoria, Illinois, United States
- Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
- Fort Wayne Medical Oncology and Hematology Inc - State Boulevard — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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