Pancreas CancerPhase 1NCT02707328
Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)
A Phase 1 study testing Gemcitabine, nab-paclitaxel and CyberKnife in people with Pancreas Cancer and Pancreatic Cancer, run by Cooper Norcross Health at 1 site in United States.
Trial summary
This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable adenocarcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas
- What is being tested?
- Gemcitabine, nab-paclitaxel and CyberKnife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 10 Nov 2017
- 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
- Pathologically confirmed adenocarcinoma of the pancreas
- Unresectable disease based on the following imaging criteria (table 1)
- extrapancreatic extension
- tumor involvement of the SMA or celiac axis
- evidence of occlusion of the SMV-portal vein confluence
- KPS > 50 (ECOG 0-2)
Show all 12Show fewer
- Age >18 years
- Women of childbearing age and male participants must practice adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and throughout study treatment.
- Life expectancy > 3 months
- Ability to understand and the willingness to sign a written informed consent.
- Note that patients with metastatic disease are eligible if it is felt that the patients will benefit from local control of the primary disease.
- Disease that is measureable or evaluable for response endpoint per RECIST
Who cannot join
- Prior radiotherapy to the upper abdomen
- Resectable or borderline resectable pancreas cancer. Note that these patients are eligible for a separate study looking at radiosurgery for borderline resectable pancreas cancer
- Severe comorbidity rendering a candidate ineligible for chemotherapy or radiation, 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.
- Patients of childbearing age who are unwilling or unable to practice contraception
- Inability to undergo MRI or CT with contrast for treatment planning
- Patients may not be receiving any other investigational nor commercial agents with therapeutic intent to treat pancreatic cancer while on this trial. Note that patients can have had previous investigational therapy but cannot have this concurrently with this protocol treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
About this study
Official title: Phase I Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)
This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable adenocarcinoma of the pancreas.
Read the detailed description
The purpose of this study is to determine the MTD for radiosurgery in the treatment of unresectable pancreas cancer, this MTD can then be used in future phase II or III studies. In terms of starting dose for the phase I study, based on the low toxicity seen in the Moffitt study we feel that 30 Gy in five fractions will be a successful starting dose.
Most of the data in unresectable is derived from patients in the metastatic setting in terms of chemotherapy agents. There have been two major studies that looked at various chemotherapy regimens versus the previous standard of care Gemzar. One study found improved survival with FOLFIRINOX and a second found that the combination of nab-paclitaxel and gemzar were superior to gemzar alone. Thus, the current standard of care for metastatic pancreas cancer (in which a local therapy like radiation has more limited role) is either FOLFIRINOX or gemzar and nab-paclitaxel. While there is some discussion of a randomized study comparing FOLFIRINOX and gemzar combined with nab-paclitaxel such a study has not started as of this time and it is unclear how much interest there would be in accruing to this study. Therefore the exact best chemotherapy regimen for metastatic disease is unclear but is either FOLFIRIONX or gemzar-nab-paclitaxel. The chemotherapy regimens for unresectable cancer are extrapolated from the metastatic setting, per NCCN guidelines any chemotherapy regimen approved for metastatic disease is reasonable to use in unresectable pancreas cancer. Thus for purpose of this study we have chosen one of the two chemotherapy regimens that have shown the best results in the metastatic setting, since there is no way to determine the exact best regimen we have chosen gemzar and nab-paclitaxel since it is felt that this is a less toxic regimen as compared to FOLFIRINOX.
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, nab-paclitaxel, CyberKnife
- Keywords
- Gemcitabine, Gemzar, CyberKnife, Cyber knife, CK, abraxane, nab-paclitaxel
- 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 gemzar
nab-paclitaxelDrug
Also called abraxane
CyberKnifeRadiation
Also called cyber knife, CK, Stereotactic radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Chemotherapy:
Gemcitabine 1000 mg/m2 and Abraxane 125 mg/m2 weekly x3 of 28 day cycle
Radiation:
20-55 GY over 5 fractions
Dosing schedule: 3 cycles of chemotherapy, followed by CyberKnife, followed by 3 additional cycles of chemotherapy. Receives: Drug: Gemcitabine; Drug: nab-paclitaxel; Radiation: CyberKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose
This study is to evaluate the MTD for Cyberknife when given in conjunction with Gemcitabine and Abraxane.
Measured: 4-7 months
Secondary outcomes (4)
overall survival
Measured: 6 months, 1 year, 5 years
Tumor response per RECIST 1.1
Measured: 4 months, 6 months, 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2 months, 6 months, 1 year
quality of life
Measured: 2 months, 4 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJan 2015
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Why it stopped: Closed after being on administrative hold
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707328
- Sponsor's protocol ID
- 14-176
- Status last verified
- Jul 2019
- First submitted
- 2 Oct 2015
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)
- ClinicalTrials.gov ID
- NCT02707328
- Acronym / sponsor ID
- 14-176
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma
- Keywords
- Gemcitabine, Gemzar, CyberKnife, Cyber knife, CK, abraxane, nab-paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed after being on administrative hold
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 14 Mar 2016 (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.
This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable adenocarcinoma of the pancreas.
Detailed description
The purpose of this study is to determine the MTD for radiosurgery in the treatment of unresectable pancreas cancer, this MTD can then be used in future phase II or III studies. In terms of starting dose for the phase I study, based on the low toxicity seen in the Moffitt study we feel that 30 Gy in five fractions will be a successful starting dose.
Most of the data in unresectable is derived from patients in the metastatic setting in terms of chemotherapy agents. There have been two major studies that looked at various chemotherapy regimens versus the previous standard of care Gemzar. One study found improved survival with FOLFIRINOX and a second found that the combination of nab-paclitaxel and gemzar were superior to gemzar alone. Thus, the current standard of care for metastatic pancreas cancer (in which a local therapy like radiation has more limited role) is either FOLFIRINOX or gemzar and nab-paclitaxel. While there is some discussion of a randomized study comparing FOLFIRINOX and gemzar combined with nab-paclitaxel such a study has not started as of this time and it is unclear how much interest there would be in accruing to this study. Therefore the exact best chemotherapy regimen for metastatic disease is unclear but is either FOLFIRIONX or gemzar-nab-paclitaxel. The chemotherapy regimens for unresectable cancer are extrapolated from the metastatic setting, per NCCN guidelines any chemotherapy regimen approved for metastatic disease is reasonable to use in unresectable pancreas cancer. Thus for purpose of this study we have chosen one of the two chemotherapy regimens that have shown the best results in the metastatic setting, since there is no way to determine the exact best regimen we have chosen gemzar and nab-paclitaxel since it is felt that this is a less toxic regimen as compared to FOLFIRINOX.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gemcitabine, Drug: nab-paclitaxel, Radiation: CyberKnifeChemotherapy: Gemcitabine 1000 mg/m2 and Abraxane 125 mg/m2 weekly x3 of 28 day cycle Radiation: 20-55 GY over 5 fractions Dosing schedule: 3 cycles of chemotherapy, followed by CyberKnife, followed by 3 additional cycles of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically confirmed adenocarcinoma of the pancreas
- Unresectable disease based on the following imaging criteria (table 1)
- KPS > 50 (ECOG 0-2)
- Age >18 years
- Women of childbearing age and male participants must practice adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and throughout study treatment.
Key exclusion criteria (6 listed)
- Prior radiotherapy to the upper abdomen
- Resectable or borderline resectable pancreas cancer. Note that these patients are eligible for a separate study looking at radiosurgery for borderline resectable pancreas cancer
- Severe comorbidity rendering a candidate ineligible for chemotherapy or radiation, 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.
- Patients of childbearing age who are unwilling or unable to practice contraception
- Inability to undergo MRI or CT with contrast for treatment planning
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: gemzar | Drug | A |
| nab-paclitaxelAlso: abraxane | Drug | A |
| CyberKnifeAlso: cyber knife, CK, Stereotactic radiosurgery | Radiation | A |
Primary outcome
Maximum tolerable dose
Time frame: 4-7 months
This study is to evaluate the MTD for Cyberknife when given in conjunction with Gemcitabine and Abraxane.
4 secondary outcomes
overall survival
Time frame: 6 months, 1 year, 5 years
Tumor response per RECIST 1.1
Time frame: 4 months, 6 months, 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 months, 6 months, 1 year
quality of life
Time frame: 2 months, 4 months, 6 months, 1 year
Results and safety
The study was stopped early (reason given: Closed after being on administrative hold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, nab-paclitaxel and CyberKnife in people with Pancreas Cancer and Pancreatic Cancer, run by Cooper Norcross Health 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 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 30 Jul 2019. 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: Closed after being on administrative hold). 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?
Maximum tolerable dose (time frame: 4-7 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 30 Jul 2019.