Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01411072
First received: August 4, 2011
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Pancreas Cancer
Drug: gemcitabine
Drug: 5-fluorouracil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Post treatment, patients will be followed every 3 months via phone call and/or electronic health record ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine Drug: gemcitabine
Gem 1000 mg/m2 IV weekly for 3 weeks then one week off of each 28 day cycle
Other Name: hENT1 high group
Experimental: 5-fluorouracil Drug: 5-fluorouracil
5-FU 425 mg/m2 and Leucovorin 20 mg/m2 IV day 1, 2, 3, 4, and 5 of each 28 day cycle
Other Name: hENT1 low group

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411072

Contacts
Contact: Jennifer Spratlin, MD, FRCPC 780-700-0842 Jennifer.Spratlin@albertahealthservices.ca
Contact: Karen Mulder, MD, FRCPC 780-432-8248 Karen.Mulder@albertahealthservices.ca

Locations
Canada, Alberta
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada
Contact: Sasha Lupichuk, MD, FRCPC, BSc    (403) 521-3093    Sasha.Lupichuk@albertahealthservices.ca   
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact: Jennifer Spratlin, MD FRCPC    780-432-8221    Jennifer.Spratlin@albertahealthservices.ca   
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Jennifer Spratlin, MD, FRCPC Cross Cancer Institute
Study Chair: Jennifer Spratlin, MD, FRCPC Cross Cancer Institute
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01411072     History of Changes
Other Study ID Numbers: Panc002/ethics 25823
Study First Received: August 4, 2011
Last Updated: October 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Biomarker directed adjuvant chemotherapy
resected pancreas cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Fluorouracil
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014