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Anti-metabolites
Gemcitabine/Nab-paclitaxel + Radiation Therapy + Surgical Resection for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Neesha Dhani, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial tests a combination of cancer treatments and radiation before surgery, followed by additional treatment after surgery. It targets patients with advanced pancreatic cancer affecting major arteries. The treatment aims to shrink the tumor and kill cancer cells before surgery, then continue to eliminate any remaining cancer cells afterward.
Who is the study for?
This trial is for under-70s with advanced pancreatic cancer affecting one major artery, but no metastases or aortic involvement. Candidates must be fit for surgery, not pregnant, agree to contraception use, and have good organ function. Exclusions include HIV/HBV/HCV infection, certain heart diseases, recent major surgery or chemo/radiotherapy to the pancreas within a year.
What is being tested?
The study tests gemcitabine/nab-paclitaxel with radiation therapy before and after surgical removal of the tumor in patients with advanced pancreatic cancer. It aims to determine safety (phase 1) and effectiveness (phase 2) of this combined treatment approach.
What are the potential side effects?
Potential side effects may include reactions from chemotherapy like nausea, fatigue, blood cell count changes leading to increased infection risk; radiation therapy might cause skin irritation or gastrointestinal symptoms; surgery carries risks such as bleeding or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gemcitabine/Nab-paclitaxel, Radiation and SurgeryExperimental Treatment4 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Surgical Resection
2018
Completed Phase 2
~420
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Gemcitabine, a DNA synthesis inhibitor, interferes with the replication of DNA, preventing cancer cells from multiplying. Nab-paclitaxel, a microtubule inhibitor, disrupts the microtubule structures essential for cell division, leading to cell death.
These mechanisms are crucial for pancreatic cancer patients as they target the rapid and uncontrolled cell division characteristic of cancer, potentially improving survival rates and quality of life.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,175 Total Patients Enrolled
Neesha Dhani, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Involvement of the aorta.You have HIV, HBV, or HCV.The vessel needs to be a certain length to be suitable.Two major arteries are affected.You have a blockage in the main vein of the liver that cannot be fixed.Your veins are affected a lot, but your arteries are not affected.You have a history of heart problems.You have had an organ transplant, heart problems, severe stomach issues, or nerve problems.Taking the medication coumadin for medical treatment.You have not had surgery to remove the tumor before.Cancer has spread to other parts of the body.You have had other types of cancer, but it has been at least 3 years since you completed treatment and have shown no signs of the disease.You have received radiation therapy or chemotherapy to the pancreas within the past year.You have moderate or severe existing nerve problems in your arms or legs.You have trouble breathing.The tumor can be removed with surgery according to current medical guidelines.You are able to perform daily activities without help or needing to rest most of the time.You have pancreatic cancer.You can use heparin for medical treatment.Your condition has gotten worse while on treatment before surgery.You have had a bone marrow transplant or stem cell rescue.You are younger than 70 years old.Your bone marrow and organs must be working well.You have been diagnosed with another type of cancer at the same time.There are no signs of the cancer spreading to other parts of the body.Your artery problem involves only one big blood vessel and can be surgically removed.It is possible to completely remove the tumor during surgery.You have kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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