Pancreatic NeoplasmsPhase 1NCT01434459
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
A Phase 1 study testing Gemcitabine with TheraSphere in people with Pancreatic Neoplasms and Cholangiocarcinoma, run by Emory University at 1 site in United States.
Trial summary
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Cholangiocarcinoma
- What is being tested?
- Gemcitabine with TheraSphere
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2014
- Phase
- Phase 1
- 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
- Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
- Liver predominant disease defined as
- Cholangiocarcinoma: liver disease should be unresectable
- Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm.
- Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis
- No prior systemic therapy for advanced stage disease
Show all 12Show fewer
- Measurable target tumors using standard imaging techniques
- Lung shunting less than 20%
- ECOG performance status 0-1 (See Appendix )
- Age ≥ 18 years
- No other investigational agents while on protocol
- Signed informed consent
Who cannot join
- Inadequate hepatic function: AST/ALT > five times upper limit of normal, Bilirubin >2.0 mg/dl or history of hepatic encephalopathy
- Inadequate renal function Creatinine > 2.0 mg/dL
- Inadequate bone marrow function: platelets < 100,000/mL or absolute neutrophil count <1500/mL
- Contraindication to angiography
- Prior external beam radiotherapy to the upper abdomen
- Clinical evidence of peritoneal metastasis or ascites
- Patients with extensive tumor replacement in the liver defined as >50% of liver involved with tumor
- Any serious ongoing extra-hepatic disease such as infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer.
The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
Read the detailed description
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.
- Conditions
- Pancreatic Neoplasms, Cholangiocarcinoma
- Being tested
- Gemcitabine with TheraSphere
- Keywords
- Pancreatic neoplasms, Cholangiocarcinoma
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine with TheraSphereDrug
Also called TheraSphere_radioembolization, Gemcitabine- Gemzar
Gemcitabine dose will be escalated and combined with therasphere.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine with TheraSphere | Experimental | Not described Receives: Drug: Gemcitabine with TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose of gemcitabine when given in combination with therasphere
Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
Measured: 28 days
Secondary outcomes (3)
Toxicities (side effects) experienced by patients on the trial
Any side effect experienced on the trial will be graded according to the grading system developed by the national cancer institute. The number of patients with each side effect will be calculated.
Measured: 90 days
Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .
Patients will receive a PET CT prior to treatment and then another PET CT scan at completion day 78. Comparison of tumor size and uptake of FDG will be performed using standard RECIST criteria
Measured: 78 days
The progression free of patients treated on the trial
The investigators will follow patients with serial cross sectional (CT or MRI) scans. If the tumor shows growth on the scan then the investigators will calculate the time it took for the tumor to grow.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2014
- Study completionSep 2014
Why it stopped: PI moved to different institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassel El-Rayes, Emory University
- Investigators
- Hyun Kevin Kim, MD, Principal investigator, Emory University Winship Cancer InstituteBassel El-Rayes, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434459
- Sponsor's protocol ID
- IRB00047233a
- Other IDs
- WCI1907-10
- Status last verified
- May 2015
- First submitted
- 12 Sep 2011
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
- ClinicalTrials.gov ID
- NCT01434459
- Acronym / sponsor ID
- IRB00047233a
- Conditions
- Pancreatic Neoplasms, Cholangiocarcinoma
- Keywords
- Pancreatic neoplasms, Cholangiocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to different institution
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Sep 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.
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer.
The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
Detailed description
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine with TheraSphere | Experimental | Drug: Gemcitabine with TheraSphere |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
- Liver predominant disease defined as
- No prior systemic therapy for advanced stage disease
- Measurable target tumors using standard imaging techniques
- Lung shunting less than 20%
Key exclusion criteria (8 listed)
- Inadequate hepatic function: AST/ALT > five times upper limit of normal, Bilirubin >2.0 mg/dl or history of hepatic encephalopathy
- Inadequate renal function Creatinine > 2.0 mg/dL
- Inadequate bone marrow function: platelets < 100,000/mL or absolute neutrophil count <1500/mL
- Contraindication to angiography
- Prior external beam radiotherapy to the upper abdomen
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 |
|---|---|---|
| Gemcitabine with TheraSphereAlso: TheraSphere_radioembolization, Gemcitabine- GemzarGemcitabine dose will be escalated and combined with therasphere. | Drug | Gemcitabine with TheraSphere |
Primary outcome
The maximum tolerated dose of gemcitabine when given in combination with therasphere
Time frame: 28 days
Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
3 secondary outcomes
Toxicities (side effects) experienced by patients on the trial
Time frame: 90 days
Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .
Time frame: 78 days
The progression free of patients treated on the trial
Time frame: 12 months
Results and safety
The study was stopped early (reason given: PI moved to different institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
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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.
Hyun Kevin Kim, MD principal investigator
Emory University Winship Cancer Institute
Bassel El-Rayes, MD principal investigator
Emory University Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine with TheraSphere in people with Pancreatic Neoplasms and Cholangiocarcinoma, run by Emory University 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 12 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: stopped early, as of the sponsor's last update on 4 May 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI moved to different institution). Results are not available in the source record.
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?
The maximum tolerated dose of gemcitabine when given in combination with therasphere (time frame: 28 days). 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 4 May 2015.