Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
Information source: AHS Cancer Control Alberta
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Cancer
Intervention: gemcitabine (Drug); 5-fluorouracil (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: AHS Cancer Control Alberta Official(s) and/or principal investigator(s): Jennifer Spratlin, MD, FRCPC, Principal Investigator, Affiliation: Cross Cancer Institute Jennifer Spratlin, MD, FRCPC, Study Chair, Affiliation: Cross Cancer Institute
Overall contact: Jennifer Spratlin, MD, FRCPC, Phone: 780-700-0842, Email: Jennifer.Spratlin@albertahealthservices.ca
Summary
Chemotherapy is given after curative surgery for pancreas cancer to try to improve cure
rates. There are two choices of chemotherapy which are currently considered equal
treatments: gemcitabine or 5-fluorouracil (5FU). This study is trying to determine if one
of two standard chemotherapies is better than the other depending on whether patients have
high or low human equilibrative nucleoside transporter 1 (hENT1). hENT1 is a protein that
is found in varying amounts on pancreas cancers.
Clinical Details
Official title: Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Survival
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
oncologist.
- 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
metastases.
- 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
study
Locations and Contacts
Jennifer Spratlin, MD, FRCPC, Phone: 780-700-0842, Email: Jennifer.Spratlin@albertahealthservices.ca
Tom Baker Cancer Center, Calgary, Alberta, Canada; Recruiting Sasha Lupichuk, MD, FRCPC, BSc, Phone: (403) 521-3093, Email: Sasha.Lupichuk@albertahealthservices.ca
Cross Cancer Institute, Edmonton, Alberta, Canada; Recruiting Jennifer Spratlin, MD FRCPC, Phone: 780-432-8221, Email: Jennifer.Spratlin@albertahealthservices.ca
Additional Information
Starting date: September 2011
Last updated: October 2, 2014
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