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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02481635
• Other study ID #: ARCAP-GA
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2016
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine

• Nab-paclitaxel

Radiation:
• Radiation Therapy

Procedure:
• Surgical Resection

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type and the severity of side effects		5 years
Secondary	Number of surviving patients at 1 year after treatment		1 year
Secondary	Number of patients who disease has not progressed		2 years
Secondary	Number of patients that are able to receive surgery after chemoradiation		5 years
Secondary	Average length of hospital stay per patient		5 years
Secondary	Number of surviving patients at 30-days after surgery		30 days after surgery
Secondary	Number of surviving patients at 90-days after surgery		90 days after surgery
Secondary	Number of patients who need to be re-admitted to the hospital at 90-days after surgery		90 days after surgery
Secondary	Time to Progression		5 years