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Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

18 Years
Open (Enrolling)
Pancreas Cancer

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Trial Information

Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

The rationale for this pilot study is based on trying to better deliver adjuvant
chemotherapy by selecting treatment for patients that is individualized based on the hENT1
biomarker. Gemcitabine (gem) requires human equilibrative nucleoside transporter 1 (hENT1)
to enter cells. If a pancreatic cancer has low hENT1, gem will not be able to enter cells
efficiently. 5-fluorouracil (5FU) does not require the same transport into cells. Thus,
upfront hENT1 testing will allow determination of therapy.

Inclusion Criteria:

- Histologically documented pancreatic adenocarcinoma not previously treated with
systemic therapy.

- Complete macroscopic and microscopic (R0) resection for ductal adenocarcinoma of the
pancreas with no evidence of malignant ascites, peritoneal metastases or distant
metastases. Lack of recurrent and/metastatic disease must be confirmed
radiologically with CT chest, abdomen, and pelvis prior to enrolment.

- Adequate tissue available for IHC testing of hENT1. Histological/cytological
confirmation of tissue to ensure sufficient material is available for hENT1 analysis
by the Cross Cancer Institute (CCI) is required. Paraffin block sufficient for
preparing ≥ 6 unstained slides for central storage and testing if required by

- ECOG performance status of 0 - 2. (Appendix B)

- Age ≥ 18 years

- Life expectancy of at least 6 months based on discretion of treating

- Adequate hematologic function defined by the following laboratory parameters:
Hemoglobin > 100, Platelet count > 100 and Absolute granulocyte count > 1.5.

- Adequate hepatic and renal function defined by the following laboratory parameters:
AST and ALT ≤ 2.5 X upper limit of institutional normal, bilirubin ≤ upper limit of
institutional normal, and calculated creatinine clearance of ≥ 50 mL/min using the
Cockcroft-Gault formula, if just below 50 mL/min based on this formula then GFR ≥ 50
mL/min as determined.

- Patients may have received prior curative radiotherapy for a different malignancy
(unless radiation was curative therapy to ≥ 25% of bone marrow stores) and patients
must have recovered from the toxic effects of this treatment.

- Patients must be started on protocol ≤ 10 weeks from the date of curative surgical
resection, and patients must have recovered from the toxic effects of surgery.

- Patients must have the ability to read, understand, and sign an informed consent and
must be willing to comply with study treatment and follow-up.

Exclusion Criteria:

- Patients who have received prior chemotherapy or radiation delivered as parts of
initial curative therapy for pancreas cancer (i.e. neoadjuvant or adjuvant
chemotherapy administered alone and/or concurrently delivered with radiation and/or
surgery) are not permitted. Metastatic patients are not permitted.

- Prior treatment for a different malignancy with > 6 cycles of traditional alkylating
agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, or concurrent
treatment with other experimental drugs or anti-cancer therapy.

- Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal

- Previous or concurrent malignancies, excluding curatively treated in situ carcinoma
of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since
last treatment and the patient is considered cured.

- Any serious medical condition within 6 months prior to study entry such as myocardial
infarction, uncontrolled congestive heart failure, unstable angina, active
cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases,
uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder,
serious infection, active peptic ulcer disease, or other medical condition that.

- Known dihydropyrimidine dehydrogenase (DPD) deficiency.

- Pregnant or lactating women; women of child bearing potential must have a negative
serum pregnancy test within 7 days of trial registration. Women or men of child
bearing potential must use effective contraception (defined by the treating
physician) which must be documented in study CRFs.

- Any other reason the investigator considers the patient should not participate in the

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Post treatment, patients will be followed every 3 months via phone call and/or electronic health record

Safety Issue:


Principal Investigator

Jennifer Spratlin, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cross Cancer Institute


Canada: Health Canada

Study ID:

Panc002/ethics 25823



Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Pancreas Cancer
  • Biomarker directed adjuvant chemotherapy
  • resected pancreas cancer
  • Pancreatic Neoplasms