A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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