Back to results

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

Primary Purpose

Pancreatic Cancer

Status

Active

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Gemcitabine

Nab-paclitaxel

Radiation Therapy

Surgical Resection

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Blood Vessels, Reconstructive Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine/Nab-paclitaxel, Radiation and Surgery

Arm 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

Outcomes

Primary Outcome Measures

Type and the severity of side effects

Secondary Outcome Measures

Number of surviving patients at 1 year after treatment

Number of patients who disease has not progressed

Number of patients that are able to receive surgery after chemoradiation

Average length of hospital stay per patient

Number of surviving patients at 30-days after surgery

Number of surviving patients at 90-days after surgery

Number of patients who need to be re-admitted to the hospital at 90-days after surgery

Time to Progression

Full Information

NCT ID

NCT02481635

First Posted

June 23, 2015

Last Updated

January 25, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02481635

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2016 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Blood Vessels, Reconstructive Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine/Nab-paclitaxel, Radiation and Surgery

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Other Intervention Name(s)

Abraxane

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Intervention Type

Procedure

Intervention Name(s)

Surgical Resection

Primary Outcome Measure Information:

Title

Type and the severity of side effects

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Number of surviving patients at 1 year after treatment

Time Frame

1 year

Title

Number of patients who disease has not progressed

Time Frame

2 years

Title

Number of patients that are able to receive surgery after chemoradiation

Time Frame

5 years

Title

Average length of hospital stay per patient

Time Frame

5 years

Title

Number of surviving patients at 30-days after surgery

Time Frame

30 days after surgery

Title

Number of surviving patients at 90-days after surgery

Time Frame

90 days after surgery

Title

Number of patients who need to be re-admitted to the hospital at 90-days after surgery

Time Frame

90 days after surgery

Title

Time to Progression

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neesha Dhani, M.D.

Organizational Affiliation

Princess Margaret Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs