Pancreatic Cancer
Conditions
Keywords
Blood Vessels, Reconstructive Surgery
Brief summary
This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.
Detailed description
Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.
Interventions
DRUGGemcitabine
DRUGNab-paclitaxel
RADIATIONRadiation Therapy
PROCEDURESurgical Resection
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Surgical: * Medically fit for major pancreatic surgery * No evidence of metastases * No prior resection * Arterial involvement limited to a single major vessel and is resectable * Tumour-free margins could be achieved * Acceptable length of vessel * Mass considered otherwise resectable by current standards General: * Less than 70 years old * Performance status \<=2 * Has pancreatic adenocarcinoma * Adequate bone marrow and organ function * Therapeutic heparin is allowed * Taking chronic erythropoietin are permitted * Not pregnant * Agree to use contraception * Able to provide written consent
Exclusion criteria
Surgical: * Aortic involvement * Involvement of 2 major arterial trunks * SMV/portal venous occlusion, cannot be reconstructed * Extensive venous involvement, no arterial involvement * Disease progression on neo-adjuvant treatme General: * Concurrent cancer diagnosis * Other malignancies unless all therapy completed, no disease for \>=3 years * Prior radiotherapy or chemo within 1 year, to pancreas * Bone marrow transplant/stem cell rescue * Major surgery \<4 wks prior * Distant metastases * Renal dysfunction * Pulmonary insufficiency * History of cardiac disease * Active systemic infection(s) or any other related illnesses * Known HIV, HBV, HCV * History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy * Conditions interfering with patient participation * Known or suspected allergy to study drugs * Pregnant or breast-feeding * Therapeutic coumadin * More than or equal to Grade 2 pre-exiting peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type and the severity of side effects | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of surviving patients at 1 year after treatment | 1 year |
| Number of patients who disease has not progressed | 2 years |
| Number of patients that are able to receive surgery after chemoradiation | 5 years |
| Average length of hospital stay per patient | 5 years |
| Number of surviving patients at 30-days after surgery | 30 days after surgery |
| Number of surviving patients at 90-days after surgery | 90 days after surgery |
| Number of patients who need to be re-admitted to the hospital at 90-days after surgery | 90 days after surgery |
| Time to Progression | 5 years |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORNeesha Dhani, M.D.
Princess Margaret Cancer Centre
Outcome results
None listed