Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Untreated Resectable Pancreatic Adenocarcinoma
Conditions
Brief summary
To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.
Interventions
combination therapy
DRUGGemcitabine
combination therapy
DRUGCisplatin
combination therapy
DRUGHydroxychloroquine
combination therapy
Sponsors
HonorHealth Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016) * Age ≥ 18 years. * If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug * If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator * Patient must have received no prior chemotherapy or radiation therapy for PDAC * Patients must have normal organ and marrow function * Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator. * Karnofsky Performance Status (KPS) of ≥70%. * Have an elevated CA 19-9 (\>2X ULN) in the context of normal bilirubin
Exclusion criteria
* Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following; Suspicious lymphadenopathy outside of the standard surgical field (i.e. aortocaval nodes, distant abdominal nodes) or Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites * Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. * Known infection with HIV, hepatitis B, or hepatitis C. * Has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study. * History of allergy or hypersensitivity to the study drugs. * Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug. * Current, serious, clinically significant cardiac arrhythmias as determined by the investigator. * Patient is unwilling or unable to comply with study procedures. * Patient is enrolled in an industry sponsored clinical trial involving treatment with investigational therapy. Patients enrolled in HonorHealth sponsored research studies may be eligible to participate as long as their participation in the other research studies does not confound the data collected for this study. * Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. * Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CA 19-9 Normalization | From enrollment to the end of study, up to 30 weeks. | Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resectability Rate (R0) | After end of treatment, from 6 months up to 2 years. | The percentage of participants whose tumors could be completely removed by surgery after receiving study regimen with no cancer cells left at margins (R0). |
| Pathologic Complete Response Rate (pCR) | After end of treatment, from 6 months up to 2 years. | Pathological complete response rate (pCR) is defined here as the absence of detectable cancer after surgical resection. Participants received a CT/MRI scan after surgical resection to monitor response using RECIST 1.1 criteria. |
| Radiological Response - Complete Response (CR) or Partial Response (PR) | From enrollment to end of study, up to 30 weeks. | Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; \>30% decrease in tumor size). |
| Radiological Response - All Responses | From enrollment to the end of study, up to 30 weeks. | Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; \>30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; \>20% increase in tumor size or new lesions). |
| 2-Year Survival | 2 years after study completion | Participants were contacted by telephone every 12 weeks to monitor survival until date of death. Participants surviving up to 2 years are reported. |
| Overall Survival | Every 12 weeks from study entry, up to 32 months. | Participants were contacted by telephone every 12 weeks to monitor survival until date of death. |
| Adverse Events Related to Study Agents | From enrollment to end of study, up to 30 weeks. | The number of patients who experienced an adverse event (AE) determined to be related to one or more of the study agents. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErkut Borazanci, MD
HonorHealth Research Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.0 Years |
| CA 19-9 | 488 U/mL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Karnofsky Performance Status (KPS) 100% | 3 Participants |
| Karnofsky Performance Status (KPS) 80% | 5 Participants |
| Karnofsky Performance Status (KPS) 90% | 4 Participants |
| Pancreatic Cancer Stage at Diagnosis Stage I | 6 Participants |
| Pancreatic Cancer Stage at Diagnosis Stage II | 3 Participants |
| Pancreatic Cancer Stage at Diagnosis Stage III | 3 Participants |
| Primary Tumor Site, Pancreas Head | 11 Participants |
| Primary Tumor Site, Pancreas Neck | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Resectability Status Borderline Resectable | 5 Participants |
| Resectability Status Resectable | 2 Participants |
| Resectability Status Unresectable (Locally Advanced) | 5 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 12 |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 7 / 12 |
Outcome results
None listed