Pancreatic CancerNCT01938716
Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy
A study testing Gemcitabine in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if gemcitabine given during surgery can enter pancreas cancer cells in patients who have already received chemotherapy and radiation. Gemcitabine is a drug used to treat pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 3 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible.
- Patients do not have known metastases.
- Patients must have potentially resectable or borderline resectable pancreatic cancer and have agreed to undergo surgical resection at MD Anderson Cancer Center if operable. They will have undergone staging (physical examination, chest x-ray, contrast enhanced CT or MRI (if CT contraindicated) and/or angiogram) to determine resectability.
- Patients have completed radiation and chemotherapy with either fluoropyrimidines (5-FU or capecitabine) or gemcitabine as a radiosensitizing agent as part of their preoperative therapy. Previous systemic chemotherapy alone is not allowed. Preoperative therapy will be completed at least 4 weeks prior to surgery.
- Patients with Karnofsky performance status > 70 are eligible.
- There will be no upper age restriction. Patients less than 18 years of age are excluded from the protocol because adenocarcinoma of the pancreas is rarely seen in the pediatric population.
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- Adequate renal and bone marrow function: Leukocytes >= 3,000/uL; Absolute neutrophil count >= 1,500/uL; Platelets >= 100,000/Ul; Serum creatinine <= 2.0 mg/dL; Creatinine clearance >= 60 ml/min (calculated by the Cockcroft -Gault equation)
- Adequate Hepatic function (endoscopic or percutaneous drainage as needed): Total bilirubin < = 3 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN
- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude administration of gemcitabine. Patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months will be excluded.
- Patient is not pregnant. Women of childbearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) and refrain from breast-feeding, as specified in the informed consent.
- Patients must sign a study-specific consent form.
Who cannot join
- Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia (NYHA [New York Heart Association] Class III and IV).
- Identification of metastatic disease.
- Patients with a known hypersensitivity to Gemcitabine.
- Pregnant women
- Inability to comply with study and/or follow-up procedures.
- Patients < 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Tissue Pharmacokinetics of Intraoperative Gemcitabine in Adenocarcinoma of the Pancreas After Preoperative Chemoradiation Therapy
The goal of this clinical research study is to learn if gemcitabine given during surgery can enter pancreas cancer cells in patients who have already received chemotherapy and radiation.
Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block the growth of cancer cells, which may cause cancer cells to die.
Read the detailed description
Surgery:
If you agree to take part in this study, your surgery will be performed in the same way as it would be even if you were not taking part in this study. You will sign a separate consent form for surgery. The length of the surgery and the time you are under anesthesia will not be changed by taking part in the study.
During surgery, you will have routine procedures to learn if the disease has spread to other areas. If the disease has spread beyond the pancreas, surgical removal will not be possible.
If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon will begin the process of removing the disease.
Study Drug Administration:
You will receive gemcitabine by vein during surgery. Gemcitabine will be given through an infusion catheter that is placed in your arm or chest in the operating room after you are asleep.
The infusion catheter is a standard-of-care procedure for all participants who are having this surgery. You will be asked to sign a separate consent form for the infusion catheter.
The infusion will take either 50 or 75 minutes, depending upon when you joined the study. The first 5 participants will receive gemcitabine over 50 minutes and the rest of the participants will receive gemcitabine over 75 minutes.
Blood and Tissue Collection:
Up to 8 blood samples (about 1 tablespoon each time) will be drawn over 70-95 minutes for pharmacokinetic (PK) testing on the day of surgery. PK testing measures the levels of study drug in your blood at different time points. The blood will also be used for biomarker testing. Biomarkers are chemical markers found in the blood and tissue that may be related to your reaction to the study drug.
Some of the tumor tissue and normal tissue removed during surgery will be collected to learn if gemcitabine is able to enter the tissue cells and for biomarker testing.
Length of Participation:
If for any reason during the surgery the surgeon decides that removal of the pancreas is not possible, you will not receive gemcitabine and your participation in this study will end.
Your active participation in this study will be over once you have had surgery and completed the follow-up.
Follow-Up:
One (1) time each day while you are in the hospital recovering from the surgery and then at the time of a routine clinic visit or by phone call at least 1 time a week, for up to 30 days after surgery, you will be asked if you have had any side effects.
This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Its use during surgery is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine
- Keywords
- Pancreatic Cancer, Adenocarcinoma of the Pancreas, Intratumoral gemcitabine levels, Pancreatic surgery, Pharmacokinetic testing, PK, Gemcitabine, Gemcitabine Hydrochloride, Gemzar
- 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 Gemcitabine Hydrochloride, Gemzar
500 mg/m2 at a fixed dose rate of 10 mg/m2/min by vein for the first 5 patients during pancreatic surgery. Next 15 subsequent patients receive 750 mg/m2 by vein at a fixed dose rate of 10 mg/m2/min.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine Infusion | Experimental | Gemcitabine administered intravenously as a dose of 500 mg/m2 at a fixed dose rate of 10 mg/m2/min for the first 5 patients (to validate hematologic safety). Next 15 subsequent patients receive 750 mg/m2 at a fixed dose rate of 10 mg/m2/min. The drug infusion started 50-75 minutes prior to complete gross tumor removal (timing dependent on dose) in order to have drug administration complete at tumor removal. Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Quantifiably Assess Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue After a Single Intraoperative Infusion in Patients.
The quantification of serum, PBMC, and cancer tissue levels of gemcitabine from frozen samples will be assessed using standardized techniques in high performance liquid chromatography-mass spectometry (HPLC/MS).
Measured: through study completion, up to 2 years and 6 months
Secondary outcomes (4)
To Measure Intra-DNA Gemcitabine (dFdC) Levels Using a Novel Assay Liquid Chromatography-mass Spectometry (LC/MS/MS).
Gemcitabine incorporation in DNA will be quantified by a proprietary LC/MS/MS method developed by Eli Lilly and performed by Advion BioServices. DNA extracted from the tissue samples to be sent to Advion.
Measured: through study completion, up to 2 years and 6 months
To Assess and Validate Previously Described Markers That May be Predictive of Gemcitabine Sensitivity or Resistance.
The mRNA level is measured using real time PCR and protein expressed by IHC, Gene expression level will be correlated to the gemcitabine measurements. Additionally measure markers of proliferation and apoptosis by p21and ki67 IHC and fluorescent TUNEL analysis.
Measured: through study completion, up to 2 years and 6 months
To Measure the Impact of Microvessel Density and the Molecular Expression Level of the Hh Signaling Pathway on Gemcitabine Delivery and DNA Incorporation.
The mRNA and protein expression of SHH, Gli, and SMO will be measured by RT-PCR and IHC method, respectively.
Measured: through study completion, up to 2 years and 6 months
To Correlate Intratumoral Gemcitabine Levels and Its Tumoricidal Activity With Ki67 Index and Intratumoral Apoptosis.
Measure markers of of proliferation and apoptosis by p21 and ki67 IHC and fluorescent TUNEL analysis.
Measured: through study completion, up to 2 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startMar 2012
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Why it stopped: Early termination due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gauri Varadhachary, MD, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938716
- Sponsor's protocol ID
- 2011-0703
- Other IDs
- NCI-2013-02211
- Status last verified
- Oct 2020
- First submitted
- 5 Sep 2013
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Pharmacokinetics of Intraoperative Gemcitabine in Adenocarcinoma of the Pancreas After Preoperative Chemoradiation Therapy
- ClinicalTrials.gov ID
- NCT01938716
- Acronym / sponsor ID
- 2011-0703
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Adenocarcinoma of the Pancreas, Intratumoral gemcitabine levels, Pancreatic surgery, Pharmacokinetic testing, PK, Gemcitabine, Gemcitabine Hydrochloride
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to low accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if gemcitabine given during surgery can enter pancreas cancer cells in patients who have already received chemotherapy and radiation.
Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block the growth of cancer cells, which may cause cancer cells to die.
Detailed description
Surgery:
If you agree to take part in this study, your surgery will be performed in the same way as it would be even if you were not taking part in this study. You will sign a separate consent form for surgery. The length of the surgery and the time you are under anesthesia will not be changed by taking part in the study.
During surgery, you will have routine procedures to learn if the disease has spread to other areas. If the disease has spread beyond the pancreas, surgical removal will not be possible.
If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon will begin the process of removing the disease.
Study Drug Administration:
You will receive gemcitabine by vein during surgery. Gemcitabine will be given through an infusion catheter that is placed in your arm or chest in the operating room after you are asleep.
The infusion catheter is a standard-of-care procedure for all participants who are having this surgery. You will be asked to sign a separate consent form for the infusion catheter.
The infusion will take either 50 or 75 minutes, depending upon when you joined the study. The first 5 participants will receive gemcitabine over 50 minutes and the rest of the participants will receive gemcitabine over 75 minutes.
Blood and Tissue Collection:
Up to 8 blood samples (about 1 tablespoon each time) will be drawn over 70-95 minutes for pharmacokinetic (PK) testing on the day of surgery. PK testing measures the levels of study drug in your blood at different time points. The blood will also be used for biomarker testing. Biomarkers are chemical markers found in the blood and tissue that may be related to your reaction to the study drug.
Some of the tumor tissue and normal tissue removed during surgery will be collected to learn if gemcitabine is able to enter the tissue cells and for biomarker testing.
Length of Participation:
If for any reason during the surgery the surgeon decides that removal of the pancreas is not possible, you will not receive gemcitabine and your participation in this study will end.
Your active participation in this study will be over once you have had surgery and completed the follow-up.
Follow-Up:
One (1) time each day while you are in the hospital recovering from the surgery and then at the time of a routine clinic visit or by phone call at least 1 time a week, for up to 30 days after surgery, you will be asked if you have had any side effects.
This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Its use during surgery is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine Infusion | Experimental | Drug: GemcitabineGemcitabine administered intravenously as a dose of 500 mg/m2 at a fixed dose rate of 10 mg/m2/min for the first 5 patients (to validate hematologic safety). Next 15 subsequent patients receive 750 mg/m2 at a fixed dose rate of 10 mg/m2/min. The drug infusion started 50-75 minutes prior to complete gross tumor removal (timing dependent on dose) in order to have drug administration complete at tumor removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible.
- Patients do not have known metastases.
- Patients must have potentially resectable or borderline resectable pancreatic cancer and have agreed to undergo surgical resection at MD Anderson Cancer Center if operable. They will have undergone staging (physical examination, chest x-ray, contrast enhanced CT or MRI (if CT contraindicated) and/or angiogram) to determine resectability.
- Patients have completed radiation and chemotherapy with either fluoropyrimidines (5-FU or capecitabine) or gemcitabine as a radiosensitizing agent as part of their preoperative therapy. Previous systemic chemotherapy alone is not allowed. Preoperative therapy will be completed at least 4 weeks prior to surgery.
- Patients with Karnofsky performance status > 70 are eligible.
Key exclusion criteria (6 listed)
- Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia (NYHA [New York Heart Association] Class III and IV).
- Identification of metastatic disease.
- Patients with a known hypersensitivity to Gemcitabine.
- Pregnant women
- Inability to comply with study and/or follow-up procedures.
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: Gemcitabine Hydrochloride, Gemzar500 mg/m2 at a fixed dose rate of 10 mg/m2/min by vein for the first 5 patients during pancreatic surgery. Next 15 subsequent patients receive 750 mg/m2 by vein at a fixed dose rate of 10 mg/m2/min. | Drug | Gemcitabine Infusion |
Primary outcome
To Quantifiably Assess Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue After a Single Intraoperative Infusion in Patients.
Time frame: through study completion, up to 2 years and 6 months
The quantification of serum, PBMC, and cancer tissue levels of gemcitabine from frozen samples will be assessed using standardized techniques in high performance liquid chromatography-mass spectometry (HPLC/MS).
4 secondary outcomes
To Measure Intra-DNA Gemcitabine (dFdC) Levels Using a Novel Assay Liquid Chromatography-mass Spectometry (LC/MS/MS).
Time frame: through study completion, up to 2 years and 6 months
To Assess and Validate Previously Described Markers That May be Predictive of Gemcitabine Sensitivity or Resistance.
Time frame: through study completion, up to 2 years and 6 months
To Measure the Impact of Microvessel Density and the Molecular Expression Level of the Hh Signaling Pathway on Gemcitabine Delivery and DNA Incorporation.
Time frame: through study completion, up to 2 years and 6 months
To Correlate Intratumoral Gemcitabine Levels and Its Tumoricidal Activity With Ki67 Index and Intratumoral Apoptosis.
Time frame: through study completion, up to 2 years and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Gauri Varadhachary, MD, MBBS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemcitabine in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Quantifiably Assess Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue After a Single Intraoperative Infusion in Patients. (time frame: through study completion, up to 2 years and 6 months). 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 5 Nov 2020.