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Anti-metabolites

FOLFOX for Pancreatic Cancer (Panc001 Trial)

Phase 3
Waitlist Available
Led By Neil S. Chua, MD, FRCPC
Research Sponsored by AHS Cancer Control Alberta
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 2 years
Awards & highlights

Panc001 Trial Summary

Chemotherapy is often used to help shrink the cancer temporarily and may improve survival for patients with incurable pancreas cancer that has spread to other organs. In Canada, the gemcitabine chemotherapy is used to treat pancreas cancer that has spread. The combination of oxaliplatin with other chemotherapies, including 5-fluorouracil, leucovorin, and irinotecan has also been studied and has benefit for patients with advanced pancreas cancer. To date, there is no test that can be done on a patient's tumour to tell if chemotherapy will work in pancreatic cancer. Human equilibrative nucleoside transporter 1 (hENT1) has been shown to be a possible predictor that gemcitabine may or may not work but this needs to be proven in a randomized study where patients get treated with gemcitabine or a different kind of chemotherapy while their tumours get tested for hENT1. This study is being done because we want to prove that hENT1 can predict if gemcitabine will work in advanced pancreas cancer and if it can, we also would like to show that a different chemotherapy combination called FOLFOX (a combination of 5-fluorouracil, leucovorin, and oxaliplatin) will be helpful for patients whose tumours don't have hENT1.

Eligible Conditions
  • Pancreatic Cancer

Panc001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference Progression Free Survival (PFS) between Gemcitabine and FOLFOX treated patients in hENT1 high and hENT1 low pancreatic adenocarcinoma.
Secondary outcome measures
Health-related quality of life (HRQL) parameters in patients with metastatic pancreas adenocarcinoma treated in both treatment arms.
The difference in overall response rate (ORR) between the two treatment arms.
The difference in overall survival (OS) between the two treatment arms.
+1 more

Panc001 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FOLFOXExperimental Treatment1 Intervention
Cycles to be 2 weeks in length Oxaliplatin 100 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 5-FUl 400 mg/m2 IV day 1 5-FU 2400 mg/m2 IV continuous infusion over 46 hours starting day 1
Group II: GemcitabineActive Control1 Intervention
Cycles to be 4 weeks in length Gemcitabine 1000 mg/m2 IV weekly for 3 weeks then one week off

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Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,037 Total Patients Enrolled
Neil S. Chua, MD, FRCPCPrincipal InvestigatorCross Cancer Institute

Frequently Asked Questions

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~14 spots leftby Apr 2025