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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 : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE June 23, 2015
First Posted Date  ICMJE June 25, 2015
Last Update Posted Date September 14, 2020
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Type and the severity of side effects [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
  • Number of surviving patients at 1 year after treatment [ Time Frame: 1 year ]
  • Number of patients who disease has not progressed [ Time Frame: 2 years ]
  • Number of patients that are able to receive surgery after chemoradiation [ Time Frame: 5 years ]
  • Average length of hospital stay per patient [ Time Frame: 5 years ]
  • Number of surviving patients at 30-days after surgery [ Time Frame: 30 days after surgery ]
  • Number of surviving patients at 90-days after surgery [ Time Frame: 90 days after surgery ]
  • Number of patients who need to be re-admitted to the hospital at 90-days after surgery [ Time Frame: 90 days after surgery ]
  • Time to Progression [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Gemcitabine
    Other Name: Gemzar
  • Drug: Nab-paclitaxel
    Other Name: Abraxane
  • Radiation: Radiation Therapy
  • Procedure: Surgical Resection
Study Arms  ICMJE 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

Interventions:
  • Drug: Gemcitabine
  • Drug: Nab-paclitaxel
  • Radiation: Radiation Therapy
  • Procedure: Surgical Resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02481635
Other Study ID Numbers  ICMJE ARCAP-GA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neesha Dhani, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP