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This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).
Full description
This study is designed to test the hypothesis that a combination of gemcitabine and radiation therapy (Gem-RT) with CPI-613®, a selective mitochondrial metabolism inhibitor in PDAC tumor cells, will be well tolerated without additional significant toxicity. Additionally, CPI-613® is expected to improve the Gem-RT effectiveness, resulting in durable local control of disease. As a necessary and initial step to translate preclinical observations into a patient setting and test our proposed hypotheses, the investigators will perform a dose-finding phase I clinical trial that has been designed to evaluate the maximum tolerated dose (MTD), recommended phase II dose (RP2D), and safety profile of CPI-613® along with standard of care Gem-RT in patients with unresectable PDAC in need of definitive local control of disease. The overarching goals for this trial are to determine the safety and toxicity of CPI-613® when given concurrently with Gem-RT.
Enrollment
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Volunteers
Inclusion criteria
Age ≥ 18 years.
Pathologically confirmed (histologic or cytologic) adenocarcinoma of the pancreas.
Patients should have an inoperable disease (locally advanced, oligometastatic, or medically inoperable) and, based on the review of the institutional pancreatic tumor board, should otherwise benefit from chemoradiation for definitive local control of the primary tumor.
Patients with and without regional adenopathy are eligible.
History/physical examination, including a collection of weight and vital signs, within 30 days prior to treatment.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 14 days of study entry.
Imaging requirements are to include
Heme Onc (Chem 24) and cancer antigen 19-9/ carcinoembryonic antigen (CEA) within 30 days prior to treatment, as follows:
Negative serum pregnancy test (if applicable).
Ability to position for radiation therapy.
Pregnancy It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below.
Female patients must meet one of the following:
Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer [ductal carcinoma in situ], or prostate cancer under active surveillance). Other malignancies are allowed if the patient has been disease free for a minimum of two years.
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection, exploratory laparotomy and laparoscopy or vascular access insertion.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Life expectancy less than two months.
Severe, active co-morbidity, defined as follows:
Serious psychiatric illness (e.g., depression, psychosis) or medical conditions that in the opinion of investigator could interfere with treatment.
Concurrent therapy with approved or investigational anticancer therapeutics other that what is stipulated by the protocol.
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or HBsAg (HBV surface antigen).
Known to be HIV seropositive and on anti-HIV drugs because of the unknown interactions between these drugs and the study agents.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 5 patient groups
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Central trial contact
Medical College of Wisconsin Cancer Center Clinical Trials Office
Data sourced from clinicaltrials.gov
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