Pancreatic CancerPhase 2NCT02242409
Study of Gemcitabine and Abraxane for Pancreas Cancer
A Phase 2 study testing Gemcitabine and Abraxane in people with Pancreatic Cancer, run by Georgetown University at 1 site in United States.
Trial summary
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting 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 and Abraxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2016
- Phase
- Phase 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 confirmed metastatic adenocarcinoma of the pancreas
- Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
- Radiographically measurable or evaluable disease
- Age >/= 18 years
- ECOG performance status 0-2
- Adequate hepatic, bone marrow and renal function
Who cannot join
- Prior gemcitabine-based chemotherapy in the first line setting
- No active severe infection, or known chronic infection with HIV or hepatitis B virus
- No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
- Patients with known CNS metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
- Anticipated patient survival under 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
Read the detailed description
This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine and Abraxane
- Keywords
- Metastatic pancreatic cancer, Second Line treatment, Gemcitabine, 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.
Gemcitabine and AbraxaneDrug
Also called Gemzar, nanoparticle-bound paclitaxel, Nab-paclitaxel
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/abraxane | Experimental | Gemcitabine and Abraxane Receives: Drug: Gemcitabine and Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 month progression free survival
The proportion of patients at 4 months from study entry with progression or death
Measured: 2.5 years
Secondary outcomes (3)
Disease control rate
Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria
Measured: 2.5 years
Progression Free Survival
The time in days from study entry until progression or death
Measured: 2.5 years
Overall Survival
The time in days from study entry until death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Testing of combination no longer relevant
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.
- More trials run by Georgetown 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Pishvaian, MD PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242409
- Sponsor's protocol ID
- LCCC 2013-0138
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02242409
- Acronym / sponsor ID
- LCCC 2013-0138
- Conditions
- Pancreatic Cancer
- Keywords
- Metastatic pancreatic cancer, Second Line treatment, Gemcitabine, Nab-paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Testing of combination no longer relevant
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Sep 2014 (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.
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
Detailed description
This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/abraxane | Experimental | Drug: Gemcitabine and AbraxaneGemcitabine and Abraxane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed metastatic adenocarcinoma of the pancreas
- Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
- Radiographically measurable or evaluable disease
- Age >/= 18 years
- ECOG performance status 0-2
Key exclusion criteria (7 listed)
- Prior gemcitabine-based chemotherapy in the first line setting
- No active severe infection, or known chronic infection with HIV or hepatitis B virus
- No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
- Patients with known CNS metastases
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 and AbraxaneAlso: Gemzar, nanoparticle-bound paclitaxel, Nab-paclitaxelGemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days | Drug | Gemcitabine/abraxane |
Primary outcome
4 month progression free survival
Time frame: 2.5 years
The proportion of patients at 4 months from study entry with progression or death
3 secondary outcomes
Disease control rate
Time frame: 2.5 years
Progression Free Survival
Time frame: 2.5 years
Overall Survival
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Testing of combination no longer relevant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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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.
Michael Pishvaian, MD PhD principal investigator
Georgetown University
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 Gemcitabine and Abraxane in people with Pancreatic Cancer, run by Georgetown 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 6 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 14 Feb 2017. 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?
The study was stopped early (reason given: Testing of combination no longer relevant). 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?
4 month progression free survival (time frame: 2.5 years). 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 14 Feb 2017.