Metastatic Pancreatic CancerPhase 2NCT01524575
Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1
A Phase 2 study testing gemcitabine and oxaliplatin in people with Metastatic Pancreatic Cancer and ERCC1, run by University of Hawaii at 1 site in United States.
Trial summary
The goal of this clinical trial is to improve and personalize pancreatic cancer care to deliver the most effective therapy while avoiding unnecessary exposure to potential side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer, ERCC1
- What is being tested?
- gemcitabine and oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- 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 or cytologically confirmed metastatic pancreatic adenocarcinoma
- Patients must not have had prior chemotherapy or biologic therapy for metastatic pancreatic cancer
- Prior adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed but must have been administered > 6 months prior to registration
- ECOG Performance Status of 0, 1, or 2
- Adequate hematologic, hepatic and renal function
Who cannot join
- Pregnant or nursing women
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years
- Patients must not have known brain metastases
- Any other condition that in the opinion of the Investigator may render the patient at excessive risk for treatment complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1 (Excision Repair Cross-complementation Group 1)
The goal of this clinical trial is to improve and personalize pancreatic cancer care to deliver the most effective therapy while avoiding unnecessary exposure to potential side effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts. The hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of ERCC1.
- Conditions
- Metastatic Pancreatic Cancer, ERCC1
- Being tested
- gemcitabine and oxaliplatin
- Keywords
- pancreatic cancer, ERCC1, oxaliplatin, gemcitabine
- 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 oxaliplatinDrug
Also called gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week
Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts.
| Study group | Role | What they receive |
|---|---|---|
| ERCC1 high expression | No intervention | Patients with ERCC1 high expression tumors will be treated at discretion of investigator |
| ERCC1 low expression | Experimental | Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin Receives: Drug: gemcitabine and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month overall survival
Measured: 6 months
Secondary outcomes (4)
Overall survival
Measured: Assessments every 2 months until 2 years or death
Progression free survival
Measured: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Best confirmed response
Measured: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Duration of overall response
Measured: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012 (estimated)
- Primary completionJul 2013 (estimated)
- Study completionJan 2014 (estimated)
Why it stopped: the trial was never opened and then withdrawn permanently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared D Acoba, MD, Principal investigator, University of Hawaii Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524575
- Sponsor's protocol ID
- CRCH0904
- Status last verified
- Sep 2019
- First submitted
- 26 Jan 2012
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1 (Excision Repair Cross-complementation Group 1)
- ClinicalTrials.gov ID
- NCT01524575
- Acronym / sponsor ID
- CRCH0904
- Conditions
- Metastatic Pancreatic Cancer, ERCC1
- Keywords
- pancreatic cancer, ERCC1, oxaliplatin, gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the trial was never opened and then withdrawn permanently
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- Jan 2012 (estimated)
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 2 Feb 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.
The goal of this clinical trial is to improve and personalize pancreatic cancer care to deliver the most effective therapy while avoiding unnecessary exposure to potential side effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts. The hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of ERCC1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCC1 high expression | No intervention | –Patients with ERCC1 high expression tumors will be treated at discretion of investigator |
| ERCC1 low expression | Experimental | Drug: gemcitabine and oxaliplatinPatients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
- Patients must not have had prior chemotherapy or biologic therapy for metastatic pancreatic cancer
- Prior adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed but must have been administered > 6 months prior to registration
- ECOG Performance Status of 0, 1, or 2
- Adequate hematologic, hepatic and renal function
Key exclusion criteria (4 listed)
- Pregnant or nursing women
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years
- Patients must not have known brain metastases
- Any other condition that in the opinion of the Investigator may render the patient at excessive risk for treatment complications
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 oxaliplatinAlso: gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2weekExcision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts. | Drug | ERCC1 low expression |
Primary outcome
6 month overall survival
Time frame: 6 months
4 secondary outcomes
Overall survival
Time frame: Assessments every 2 months until 2 years or death
Progression free survival
Time frame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Best confirmed response
Time frame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Duration of overall response
Time frame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
Jared D Acoba, MD principal investigator
University of Hawaii Cancer Research Center
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 oxaliplatin in people with Metastatic Pancreatic Cancer and ERCC1, run by University of Hawaii 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 Sep 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 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 withdrawn before enrolling participants, so there are no results.
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?
6 month overall survival (time frame: 6 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 25 Sep 2019.