Pancreatic AdenocarcinomaPhase 2NCT01206296
Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
A Phase 2 study testing Intraperitoneal Gemcitabine in people with Pancreatic Adenocarcinoma, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer. The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Intraperitoneal Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2014
- Phase
- Phase 2
- 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
- Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas or periampullary cancer (duodenum, ampulla of Vater or distal common bile duct).
- Patients without a histologically confirmed diagnosis prior to surgical exploration, will have intraoperative frozen section to confirm the diagnosis prior to the administration of intraoperative intraperitoneal gemcitabine.
- Patients must undergo adequate preoperative imaging evaluation to determine resectability including contrast enhanced CT scan or MRI with or without endoscopic ultrasound
- Patients must have a complete surgical resection to grossly negative margins. The margins will be assessed in a routine fashion: the surgeon will decide on the level of transection based on visual inspection making sure that the visible/palpable tumor is removed with a negative margin. The specimen will be assessed for pancreatic duct and bile duct margin by intraoperative frozen section and an attempt will be made to have microscopically negative margins in all cases.
- Patients who have not received chemotherapy for the treatment of their pancreatic cancer prior to surgery scheduled at the Washington Hospital Center may be included in the protocol.
- Age >18 years. Because no dosing or adverse event data are currently available on the use of gemcitabine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.
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- Life expectancy of greater than 6 months
- ECOG (Eastern Cooperative Oncology Group) performance status <2
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- total bilirubin within normal institutional limits or compatible with preoperative biliary obstruction caused by the tumor
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal or compatible with preoperative biliary obstruction caused by the tumor
- creatinine within normal institutional limits OR
- creatinine clearance >45 mL/min
- The effects of gemcitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to avoid pregnancy prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had radiotherapy or chemotherapy for their pancreatic cancer
- Patients receiving any other investigational agents.
- Patients with metastatic disease in the liver or other distant sites, intraabdominal lymph nodes beyond regional draining lymph nodes or with malignant ascites
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because gemcitabine is an antimetabolite (pyrimidine analog) with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with gemcitabine. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.
The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma.
The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Intraperitoneal Gemcitabine
- Keywords
- Adjuvant, Intraperitoneal, Gemcitabine, Pancreas, Adenocarcinoma
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal GemcitabineDrug
Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2
Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal Gemcitabine | Experimental | Intraperitoneal Gemcitabine Receives: Drug: Intraperitoneal Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade III and IV Complications
Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
Measured: Occurring during hospitalization or within 30 days of surgery, whichever is longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Study suspended
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 AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lana Bijelic, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206296
- Sponsor's protocol ID
- WCI 2009-455
- Status last verified
- Feb 2021
- First submitted
- 20 Sep 2010
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01206296
- Acronym / sponsor ID
- WCI 2009-455
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Adjuvant, Intraperitoneal, Gemcitabine, Pancreas, Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Posted 10 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.
The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma.
The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal Gemcitabine | Experimental | Drug: Intraperitoneal GemcitabineIntraperitoneal Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas or periampullary cancer (duodenum, ampulla of Vater or distal common bile duct).
- Patients without a histologically confirmed diagnosis prior to surgical exploration, will have intraoperative frozen section to confirm the diagnosis prior to the administration of intraoperative intraperitoneal gemcitabine.
- Patients must undergo adequate preoperative imaging evaluation to determine resectability including contrast enhanced CT scan or MRI with or without endoscopic ultrasound
- Patients must have a complete surgical resection to grossly negative margins. The margins will be assessed in a routine fashion: the surgeon will decide on the level of transection based on visual inspection making sure that the visible/palpable tumor is removed with a negative margin. The specimen will be assessed for pancreatic duct and bile duct margin by intraoperative frozen section and an attempt will be made to have microscopically negative margins in all cases.
- Patients who have not received chemotherapy for the treatment of their pancreatic cancer prior to surgery scheduled at the Washington Hospital Center may be included in the protocol.
Key exclusion criteria (7 listed)
- Patients who have had radiotherapy or chemotherapy for their pancreatic cancer
- Patients receiving any other investigational agents.
- Patients with metastatic disease in the liver or other distant sites, intraabdominal lymph nodes beyond regional draining lymph nodes or with malignant ascites
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Intraperitoneal GemcitabineStandard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2 Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles | Drug | Intraperitoneal Gemcitabine |
Primary outcome
Grade III and IV Complications
Time frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer
Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Washington Hospital CenterLink 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.
Lana Bijelic, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intraperitoneal Gemcitabine in people with Pancreatic Adenocarcinoma, run by Medstar Health Research Institute 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 18 inclusion and 7 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 9 Mar 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2021). 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?
Grade III and IV Complications (time frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer). 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 9 Mar 2021.