CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer (NCT01835041) | Clinical Trial Compass
CompletedPhase 1
CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer
United States21 participantsStarted 2013-04
Plain-language summary
This phase I trial studies the side effects and best dose of CPI-613 when given together with combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically and cytologically confirmed metastatic pancreatic adenocarcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status being 0-1
* Expected survival \> 2 months
* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
* Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists
* At least 2 weeks must have elapsed from any prior surgery or hormonal therapy
* Granulocyte count \>= 1500/mm\^3
* White blood cell (WBC) \>= 3500 cells/mm\^3 or \>= 3.5 bil/L
* Platelet count \>= 100,000 cells/mm\^3 or \>= 100 bil/L
* Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3 or \>= 1.5 bil/L
* Hemoglobin \>= 9 g/dL or \>= 90 g/L
* Aspartate aminotransferase (AST/serum glutamic oxalic transaminase \[SGOT\]) =\< 3 x upper normal limit (UNL), alanine aminotransferase (ALT/serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x UNL (=\< 5 x UNL if liver metastases present)
* Bilirubin =\< 1.5 x UNL
* Serum creatinine =\< 2.0 mg/dL or 177 µmol/L
* International normalized ratio or INR must be =\< 1.5 unless on therapeutic blood thinners
* No evidence of active infection and no serious infection within the pa…