Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
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|ClinicalTrials.gov Identifier: NCT01411072|
Recruitment Status : Unknown
Verified October 2014 by AHS Cancer Control Alberta.
Recruitment status was: Recruiting
First Posted : August 8, 2011
Last Update Posted : October 3, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Drug: gemcitabine Drug: 5-fluorouracil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||December 2015|
Gem 1000 mg/m2 IV weekly for 3 weeks then one week off of each 28 day cycle
Other Name: hENT1 high group
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
- Overall Survival [ Time Frame: Post treatment, patients will be followed every 3 months via phone call and/or electronic health record ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411072
|Contact: Jennifer Spratlin, MD, FRCPC||780-700-0842||Jennifer.Spratlin@albertahealthservices.ca|
|Contact: Karen Mulder, MD, FRCPC||780-432-8248||Karen.Mulder@albertahealthservices.ca|
|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|
|Principal Investigator:||Jennifer Spratlin, MD, FRCPC||Cross Cancer Institute|
|Study Chair:||Jennifer Spratlin, MD, FRCPC||Cross Cancer Institute|
|Responsible Party:||AHS Cancer Control Alberta|
|Other Study ID Numbers:||
|First Posted:||August 8, 2011 Key Record Dates|
|Last Update Posted:||October 3, 2014|
|Last Verified:||October 2014|
Biomarker directed adjuvant chemotherapy
resected pancreas cancer
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs