Pancreas CancerNCT01411072
Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
A study testing gemcitabine and 5-fluorouracil in people with Pancreas Cancer, run by AHS Cancer Control Alberta at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- gemcitabine and 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Tom Baker Cancer Center
Calgary, Alberta
Sasha Lupichuk, MD, FRCPC, BSc, (403) 521-3093, Sasha.Lupichuk@albertahealthservices.ca
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
Jennifer Spratlin, MD FRCPC, 780-432-8221, Jennifer.Spratlin@albertahealthservices.ca
About this study
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.
Read the 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.
- Conditions
- Pancreas Cancer
- Being tested
- gemcitabine, 5-fluorouracil
- Keywords
- Biomarker directed adjuvant chemotherapy, resected pancreas cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Also called hENT1 high group
Gem 1000 mg/m2 IV weekly for 3 weeks then one week off of each 28 day cycle
5-fluorouracilDrug
Also called hENT1 low group
5-FU 425 mg/m2 and Leucovorin 20 mg/m2 IV day 1, 2, 3, 4, and 5 of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Experimental | Not described Receives: Drug: gemcitabine |
| 5-fluorouracil | Experimental | Not described Receives: Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Post treatment, patients will be followed every 3 months via phone call and/or electronic health record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Spratlin, MD, FRCPC, Principal investigator, Cross Cancer InstituteJennifer Spratlin, MD, FRCPC, Study chair, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411072
- Sponsor's protocol ID
- Panc002/ethics 25823
- Status last verified
- Oct 2014
- First submitted
- 4 Aug 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
- ClinicalTrials.gov ID
- NCT01411072
- Acronym / sponsor ID
- Panc002/ethics 25823
- Conditions
- Pancreas Cancer
- Keywords
- Biomarker directed adjuvant chemotherapy, resected pancreas cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Experimental | Drug: gemcitabine |
| 5-fluorouracil | Experimental | Drug: 5-fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabineAlso: hENT1 high groupGem 1000 mg/m2 IV weekly for 3 weeks then one week off of each 28 day cycle | Drug | Gemcitabine |
| 5-fluorouracilAlso: hENT1 low group5-FU 425 mg/m2 and Leucovorin 20 mg/m2 IV day 1, 2, 3, 4, and 5 of each 28 day cycle | Drug | 5-fluorouracil |
Primary outcome
Overall Survival
Time frame: Post treatment, patients will be followed every 3 months via phone call and/or electronic health record
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Spratlin, MD, FRCPC principal investigator
Cross Cancer Institute
Jennifer Spratlin, MD, FRCPC study chair
Cross Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gemcitabine and 5-fluorouracil in people with Pancreas Cancer, run by AHS Cancer Control Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Spratlin, MD, FRCPC (780-700-0842, Jennifer.Spratlin@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Post treatment, patients will be followed every 3 months via phone call and/or electronic health record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.