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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
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)

Awards & Highlights

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.

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
1,519 Previous Clinical Trials
503,041 Total Patients Enrolled
Neesha Dhani, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02481635 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02481635 — Phase 1 & 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02481635 — Phase 1 & 2
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