Adenocarcinoma of PancreasPhase 2NCT01359007
FOLFIRINOX in Patients With Inoperable Pancreatic Cancer
A Phase 2 study testing Irinotecan, Oxaliplatin, Leucovorin, 5-FU in people with Adenocarcinoma of Pancreas, run by University of Oklahoma at 1 site in United States.
Trial summary
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adenocarcinoma of Pancreas
- What is being tested?
- Irinotecan, Oxaliplatin, Leucovorin, 5-FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
- Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
- No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
- Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age
- Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
- Patients must have adequate blood counts at baseline and blood chemistry levels
- Patient has ECOG Performance Status 0 to 1
Who cannot join
- Patients with islet cell neoplasms excluded
- Patients with known brain metastases
- Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known infection with HIV, hepatitis B or hepatitis C
- Major surgery or vascular device placement within 4 weeks prior to Day 1 of treatment in study
Show all 14Show fewer
- Prior chemotherapy or radiation for pancreatic cancer
- History of allergy or hypersensitivity to the study drugs
- Patient is enrolled in any other clinical protocol or investigational trial
- Metastatic disease on radiological staging
- Prior malignancy within last 3 years
- Significant cardiac disease
- Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk
- peripheral sensory neuropathy > or equal to grade 2 at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.
- Conditions
- Adenocarcinoma of Pancreas
- Being tested
- Irinotecan, Oxaliplatin, Leucovorin, 5-FU
- Keywords
- Locally advanced unresectable adenocarcinoma of pancreas, Borderline resectable adenocarcinoma of pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan, Oxaliplatin, Leucovorin, 5-FUDrug
5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Receives: Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Measured: 2 years
Secondary outcomes (4)
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Measured: 2 years
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Measured: 2 years
Overall Survival
Measured: 2 years
Number of Participants Who Experienced Toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: The principal investigator terminated the study due to inactivity and low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of PancreasStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shubham Pant, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359007
- Sponsor's protocol ID
- 1977
- Status last verified
- Feb 2018
- First submitted
- 23 May 2011
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT01359007
- Acronym / sponsor ID
- 1977
- Conditions
- Adenocarcinoma of Pancreas
- Keywords
- Locally advanced unresectable adenocarcinoma of pancreas, Borderline resectable adenocarcinoma of pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The principal investigator terminated the study due to inactivity and low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FUCombination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
- Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
- No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
- Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age
- Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
Key exclusion criteria (14 listed)
- Patients with islet cell neoplasms excluded
- Patients with known brain metastases
- Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known infection with HIV, hepatitis B or hepatitis C
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 |
|---|---|---|
| Irinotecan, Oxaliplatin, Leucovorin, 5-FU5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently | Drug | FOLFIRINOX |
Primary outcome
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Time frame: 2 years
4 secondary outcomes
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Time frame: 2 years
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Time frame: 2 years
Overall Survival
Time frame: 2 years
Number of Participants Who Experienced Toxicity
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shubham Pant, MD principal investigator
University of Oklahoma
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 Irinotecan, Oxaliplatin, Leucovorin, 5-FU in people with Adenocarcinoma of Pancreas, run by University of Oklahoma 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 14 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 9 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy. (time frame: 2 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 9 Mar 2018.