Clinical trial NCT02481635: A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
Official title: A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Blood Vessels
Reconstructive Surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Type and the severity of side effects
timeFrame: 5 years
Secondary outcomes:
measure: Number of surviving patients at 1 year after treatment
timeFrame: 1 year
measure: Number of patients who disease has not progressed
timeFrame: 2 years
measure: Number of patients that are able to receive surgery after chemoradiation
timeFrame: 5 years
measure: Average length of hospital stay per patient
timeFrame: 5 years
measure: Number of surviving patients at 30-days after surgery
timeFrame: 30 days after surgery
measure: Number of surviving patients at 90-days after surgery
timeFrame: 90 days after surgery
measure: Number of patients who need to be re-admitted to the hospital at 90-days after surgery
timeFrame: 90 days after surgery
measure: Time to Progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Neesha Dhani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: