Status:
COMPLETED
CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 chemotherap...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of CPI-613 (6,8-bis\[benzylthio\]octanoic acid), when used in combination with modified leucovorin calcium, fluorouracil, irinotec...
Eligibility Criteria
Inclusion
- 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 past month
- Mentally competent, ability to understand and willingness to sign the informed consent form
Exclusion
- Endocrine or acinar pancreatic carcinoma
- Previous radiotherapy for cerebral metastases, central nervous system (CNS) or epidural tumor
- Prior treatment with any chemotherapy for metastatic disease from pancreatic cancer
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 4 weeks prior to initiation of CPI-613 treatment
- Serious medical illness that would potentially increase patients' risk for toxicity
- Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
- Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown)
- Lactating females
- Fertile men unwilling to practice contraceptive methods during the study period
- Life expectancy less than 2 months
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
- Unwilling or unable to follow protocol requirements
- Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure
- Patients with a history of myocardial infarction that is \< 3 months prior to registration
- Evidence of active infection, or serious infection within the past month
- Patients with known human immunodeficiency virus (HIV) infection
- Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
- Requirement for immediate palliative treatment of any kind including surgery
- Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01835041
Start Date
April 1 2013
End Date
March 16 2023
Last Update
July 12 2023
Active Locations (1)
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1
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157