Metastatic Pancreatic CancerPhase 2NCT02028806
mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing mFOLFIRINOX in people with Metastatic Pancreatic Cancer, run by Yuhong Li at 1 site in China.
Trial summary
This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have provided a signed Informed Consent Form
- ECOG performance status of 0-1
- BMI ≥ 18.5
- Age: 18-65 years old
- Histologically confirmed diagnosis of metastatic pancreatic cancer
- No prior palliative chemotherapy
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- Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
- Life expectancy ≥ 3 months
- Patient has adequate bone marrow and organ function
- Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L
- Platelets ≥ 90 x 109/L
- Hemoglobin ≥ 90 g/L
- Patient has adequate liver function
- AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
- Serum bilirubin ≤ 1.2 x ULN
- Creatinine ≤ 1.25 times ULN
- Good compliance
Who cannot join
- Pregnant or lactating women
- Brain metastasis or only with bone metastasis.
- Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
- Refuse to take appropriate contraceptive measures (including male patients).
- Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
- Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
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- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
- Psychiatric illness that would prevent the patient from giving informed consent.
- Patient is concurrently using other antineoplastic agent
- Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
- Known HIV-positivity.
- No history of chronic diarrhea, nausea or vomit.
- No ≥ grade 2 sensory peripheral neuropathy.
- A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
- Infectious disease or inflammation with body temperature ≥ 38 ℃.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ⅱ Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China
This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
Read the detailed description
Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- mFOLFIRINOX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOXDrug
Also called Oxaliplatin, Irinotecan, Leucovorin, 5-Fluorouracial
Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion. Receives: Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
Measured: Up to 24 weeks
Secondary outcomes (4)
Progression free survival
Measured: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Measured: From the date of first drug administration until the date of death, assessed up to 60 months
Number of participants with AEs and SAEs as a measure of Safety
Safety data will be assessed at each study visit using NCI CTCAE version 3.0
Measured: Each follow up visit, assessed up to 24 weeks
EORTC QLQ-C30
Quality of life will be assessed at each study using EORTC QLQ-C30
Measured: Each follow up visit, assessed 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 posted7 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhong Li, Sun Yat-sen University
- Investigators
- Li Yuhong, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028806
- Sponsor's protocol ID
- PAN-321
- Status last verified
- Feb 2023
- First submitted
- 1 Jan 2014
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang ZQ, Zhang F, Deng T, Zhang L, Feng F, Wang FH, Wang W, Wang DS, Luo HY, Xu RH, Ba Y, Li YH. The efficacy and safety of modified FOLFIRINOX as first-line chemotherapy for Chinese patients with metastatic pancreatic cancer. Cancer Commun (Lond). 2019 May 8;39(1):26. doi: 10.1186/s40880-019-0367-7.
PubMed 31068222
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China
- ClinicalTrials.gov ID
- NCT02028806
- Acronym / sponsor ID
- PAN-321
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuhong LiUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Jan 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.
This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
Detailed description
Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
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: mFOLFIRINOXPatients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients have provided a signed Informed Consent Form
- ECOG performance status of 0-1
- BMI ≥ 18.5
- Age: 18-65 years old
- Histologically confirmed diagnosis of metastatic pancreatic cancer
Key exclusion criteria (15 listed)
- Pregnant or lactating women
- Brain metastasis or only with bone metastasis.
- Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
- Refuse to take appropriate contraceptive measures (including male patients).
- Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
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 |
|---|---|---|
| mFOLFIRINOXAlso: Oxaliplatin, Irinotecan, Leucovorin, 5-FluorouracialPatients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion. | Drug | FOLFIRINOX |
Primary outcome
Disease control rate
Time frame: Up to 24 weeks
4 secondary outcomes
Progression free survival
Time frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Time frame: From the date of first drug administration until the date of death, assessed up to 60 months
Number of participants with AEs and SAEs as a measure of Safety
Time frame: Each follow up visit, assessed up to 24 weeks
EORTC QLQ-C30
Time frame: Each follow up visit, assessed up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 31068222Wang ZQ, Zhang F, Deng T, Zhang L, Feng F, Wang FH, Wang W, Wang DS, Luo HY, Xu RH, Ba Y, Li YH. The efficacy and safety of modified FOLFIRINOX as first-line chemotherapy for Chinese patients with metastatic pancreatic cancer. Cancer Commun (Lond). 2019 May 8;39(1):26. doi: 10.1186/s40880-019-0367-7.
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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.
Li Yuhong, MD principal investigator
Sun Yat-sen 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 mFOLFIRINOX in people with Metastatic Pancreatic Cancer, run by Yuhong Li at 1 site in China.
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 17 inclusion and 15 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: finished, as of the sponsor's last update on 16 Feb 2023. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease control rate (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02028806, which also lists 1 linked publication.
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 16 Feb 2023.