Status:
COMPLETED
CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Mucinous Adenocarcinoma of the Colon
Mucinous Adenocarcinoma of the Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This pilot phase I trial studies the side effects and best dose of CPI-613 when given together with fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body ...
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 5-FU (fluorouracil), in patients with non-resectabl...
Eligibility Criteria
Inclusion
- Histologically and cytologically confirmed metastatic colorectal adenocarcinoma (colon, rectal or colorectal cancer) that is not resectable
- Have failed or have not tolerated FOLFOX, FOLFIRI and, if KRAS wild type, then a EGFR inhibitor-based regimen
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2
- 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
- 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 oxaloacetic 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 =\< 1.5 mg/dL or 13 umol/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
- At least one measurable lesion as assessed by computed tomography (CT) scan using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Exclusion
- Therapy with CPI-613 prior to participating in this trial
- Known hypersensitivity to 5-FU injection, poor nutritional state, known dipyrimidine dehydrogenase deficiency, or taking sorivudine (such as Usevir, brovavir, etc.)
- History of hypersensitivity to active or inactive excipients of any component of treatment
- Previous radiotherapy for central nervous system metastases
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
- 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)
- History of abdominal fistula or gastrointestinal perforation =\< 6 months prior to treatment with study drugs
- Pregnant women, or women of child-bearing potential not using reliable means of contraception
- Lactating females
- Fertile men unwilling to practice contraceptive methods during the study period
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
- Unwilling or unable to follow protocol requirements
- Symptomatic 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, hepatitis B, or hepatitis C
- Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment; steroid use for management of refractory pain or for contrast induced allergy is allowed
- Requirement for immediate palliative treatment of any kind including surgery
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Key Trial Info
Start Date :
January 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02232152
Start Date
January 6 2015
End Date
January 11 2023
Last Update
August 7 2023
Active Locations (1)
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1
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157