Pancreatic Cancer
Conditions
Keywords
PEGPH20, Cetuximab, 14-039
Brief summary
This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be studied. Also, the effects of PEGPH20 on tumors will be studied.
Interventions
DRUGPEGPH20
DRUGCetuximab
DEVICEDW & DCE-MRI
OTHERblood draws
Blood samples will be drawn at various time points.
Sponsors
Cold Spring Harbor Laboratory
Weizmann Institute of Science
Memorial Sloan Kettering Cancer Center
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
* Patients must have histologically or cytologically confirmed PDAC. Pathologic confirmation is mandated before initiation of any protocol specified imaging studies or drug administrations. It is recognized that for some patients, histologic or cytologic confirmation of cancer may be obtained following study enrollment. Patient volunteers to the DW- and DCE-MRI sequence parameter optimization imaging portion of the study are eligible if they have any pancreatic lesion, histologic or cytologic confirmation of pathology is not required for this patient volunteer group. * Radiographically resectable PDAC as adjudicated by MSKCC surgical oncologist without evidence of distant metastases by CT or by laparoscopy, if performed at the discretion of the surgeon. * Age \> 18 years. * ECOG Performance Score of 0 - 2. * Absolute neutrophil count \> 1,500 cells/mm3 * Platelet count \> 100,000 cells/mm3. * Adequate renal function as evidenced by serum creatinine \< 1.6 mg/dL. * INR \< 1.5, unless patient is on therapeutic anticoagulation where a therapeutic INR is acceptable. Anticoagulation with low molecular weight heparin or warfarin, where medically indicated, is permitted. * Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion of the study are exempt from criteria 2, 5, 6 and 8. * Women of childbearing potential must have a negative pregnancy test prior to the administration of protocol specified interventions. * Ability to understand informed consent and signing of written informed consent prior to initiation of protocol therapy.
Exclusion criteria
* Patients with histology other than adenocarcinoma, e.g., neuroendocrine cancer or acinar cancers, are ineligible. * No prior therapy for pancreas cancer is allowed. * Patients with metastatic or locally unresectable PDAC (resectability is as defined by MSKCC pancreatic surgeon and as outlined * Active infection, with the exception of resolving cholangitis, will preclude enrollment on the study. Preoperative interventions can only be initiated when acute cholangitis has resolved. * Patients with known hypersensitivity to any of the components of PEGPH20 or cetuximab. * For patients who choose to undergo MRI imaging, hypersensitivity to MRI IV contrast media not suitable for pre-medication. * Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). * Patients who have a history of venous or arterial thromboembolic events including pulmonary embolism, deep venous thrombosis and stroke. * Patients who are pregnant or lactating * For patients who choose to undergo MRI imaging patients who are ineligible for an MRI with contrast based on Radiology Department screening. * Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures. * Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion are exempt from criteria 12, 13, 14, 15, 16 and 18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of PEGPH20 | 1 year | administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Administration of PEGPH20 and Cetuximab | 1 year | in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized. |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual 09/12/2014 Protocol Closed to Accrual N/A Primary Completion Date 09/13/2016 Recruitment Location is the medical clinic
Participants by arm
| Arm | Count |
|---|---|
| PEGPH20 And Cetuximab Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.
However, the two participants accrued to this study were healthy participants. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol closed due to lack of accrual. | 2 |
Baseline characteristics
| Characteristic | PEGPH20 And Cetuximab |
|---|---|
| Age, Continuous | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 2 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Effects of PEGPH20
administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.
Time frame: 1 year
Population: The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.
Secondary
Safety of Administration of PEGPH20 and Cetuximab
in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.
Time frame: 1 year
Population: The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.