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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02481635
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Nab-paclitaxel Radiation: Radiation Therapy Procedure: Surgical Resection Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Gemcitabine/Nab-paclitaxel, Radiation and Surgery

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

Drug: Gemcitabine
Other Name: Gemzar

Drug: Nab-paclitaxel
Other Name: Abraxane

Radiation: Radiation Therapy
Procedure: Surgical Resection



Primary Outcome Measures :
  1. Type and the severity of side effects [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of surviving patients at 1 year after treatment [ Time Frame: 1 year ]
  2. Number of patients who disease has not progressed [ Time Frame: 2 years ]
  3. Number of patients that are able to receive surgery after chemoradiation [ Time Frame: 5 years ]
  4. Average length of hospital stay per patient [ Time Frame: 5 years ]
  5. Number of surviving patients at 30-days after surgery [ Time Frame: 30 days after surgery ]
  6. Number of surviving patients at 90-days after surgery [ Time Frame: 90 days after surgery ]
  7. Number of patients who need to be re-admitted to the hospital at 90-days after surgery [ Time Frame: 90 days after surgery ]
  8. Time to Progression [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481635


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Neesha Dhani, M.D. Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02481635    
Other Study ID Numbers: ARCAP-GA
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Keywords provided by University Health Network, Toronto:
Blood Vessels
Reconstructive Surgery
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs