Pancreatic CancerPhase 1/2NCT01693276
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
A Phase 1/2 study testing Gemcitabine, Abraxane and Radiation Therapy in people with Pancreatic Cancer, run by Olugbenga Olowokure at 1 site in United States.
Trial summary
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. 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, Abraxane and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2014
- Phase
- Phase 1/2
- 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 or cytologically proven carcinoma of the pancreas that is locally advanced
- ECOG performance status 0- 2
- Adequate labs
- No prior abdominal radiation therapy
- No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
- All disease must be encompassed within a radiotherapy portal
- Not pregnant or nursing
Who cannot join
- Patient has metastatic disease on radiological staging
- systemic therapy.
- Patient has known active infection with HIV, hepatitis C or hepatitis B
- Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
- Patient is deemed to be have obvious resectable disease at presentation
- Received any investigational agent within a month prior to enrollment.
- Neuroendocrine tumors of the pancreas
Trial locations and contacts
1 site in 1 country.
About this study
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.
Read the detailed description
The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Abraxane, Radiation Therapy
- Keywords
- pancreatic 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 Gemzar
gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT.
Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks.
AbraxaneDrug
Also called nab-Paclitaxel
Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT
Radiation TherapyRadiation
Also called RT
IMRT Dose escalation: 60 Gy (2 Gy/fraction)
| Study group | Role | What they receive |
|---|---|---|
| Gemzar/Abraxane and Radiation Therapy | Experimental | Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given. Receives: Drug: Gemcitabine; Drug: Abraxane; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase overall survival
Estimated increase in median survival from 11 to 16 months
Measured: 23 months
Secondary outcomes (1)
Rate of local control
Determine rate of local control from the date of start of treatment to the date of the time of local progression
Measured: baseline to average up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olugbenga Olowokure
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olugbenga Olowokure, University of Cincinnati
- Investigators
- Olugbenga Olowokure, MD, Principal investigator, University of CincinnatiMichelle Mierzwa, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693276
- Sponsor's protocol ID
- UCC-GI-01
- Status last verified
- Oct 2015
- First submitted
- 19 Sep 2012
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01693276
- Acronym / sponsor ID
- UCC-GI-01
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Olugbenga OlowokureUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Sep 2012 (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 will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.
Detailed description
The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemzar/Abraxane and Radiation Therapy | Experimental | Drug: Gemcitabine, Drug: Abraxane, Radiation: Radiation TherapyPatients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven carcinoma of the pancreas that is locally advanced
- ECOG performance status 0- 2
- Adequate labs
- No prior abdominal radiation therapy
- No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
Key exclusion criteria (7 listed)
- Patient has metastatic disease on radiological staging
- systemic therapy.
- Patient has known active infection with HIV, hepatitis C or hepatitis B
- Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
- Patient is deemed to be have obvious resectable disease at presentation
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: Gemzargemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT. Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks. | Drug | Gemzar/Abraxane and Radiation Therapy |
| AbraxaneAlso: nab-PaclitaxelAbraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT | Drug | Gemzar/Abraxane and Radiation Therapy |
| Radiation TherapyAlso: RTIMRT Dose escalation: 60 Gy (2 Gy/fraction) | Radiation | Gemzar/Abraxane and Radiation Therapy |
Primary outcome
Increase overall survival
Time frame: 23 months
Estimated increase in median survival from 11 to 16 months
1 secondary outcome
Rate of local control
Time frame: baseline to average up to 24 weeks
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
Olugbenga Olowokure, MD principal investigator
University of Cincinnati
Michelle Mierzwa, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine, Abraxane and Radiation Therapy in people with Pancreatic Cancer, run by Olugbenga Olowokure 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 7 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 26 Oct 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 combined 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.
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?
The study was stopped early (reason given: Slow accrual). 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?
Increase overall survival (time frame: 23 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 26 Oct 2015.