CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin; Thioctic Acid

Criteria

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 past month

• Mentally competent, ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

• 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