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

University Health Network, Toronto

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Procedure: Surgical Resection; Drug: Nab-paclitaxel; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02481635

ARCAP-GA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Gemcitabine/Nab-paclitaxel, Radiation and Surgery

Experimental group

Description:

Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction

Treatment:

Radiation: Radiation Therapy

Drug: Nab-paclitaxel

Procedure: Surgical Resection

Drug: Gemcitabine