Metastatic Pancreatic CancerPhase 2NCT04672005
Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel Untreated Pancreatic Cancer
A Phase 2 study testing Folfirinox alternating with Gemcitabine-nab-Paclitaxel in people with Metastatic Pancreatic Cancer, run by Lyudmyla Berim at 7 sites in United States.
Trial summary
The main objective of the clinical trial is to determine if modified FOLFIRINOX (mFFX) alternated with biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP) administered as a combined, front-line therapy will result in longer time to treatment failure (TTF) compared to the current standard of care with mFFX alone in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Folfirinox alternating with Gemcitabine-nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Jan 2021to 1 Jun 2025
- 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 and/or cytologically confirmed pancreatic adenocarcinoma.
- Stage IV disease. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data.
- Subject must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a subject received prior neoadjuvant or adjuvant chemotherapy, tumor recurrence must have occurred more than 6 months after completing the last dose of chemotherapy.
- ECOG performance status of 0-1.
- At least 18 years of age.
- Evidence of measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy.
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- Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male and female patients must agree to use effective barrier contraception during the period of therapy.
- Adequate bone marrow function:
- 8a. ANC ≥ 1500/uL 8b.platelet count ≥ 100,000/uL 8c. hemoglobin ≥ 9.0 g/dL 9. Adequate hepatic function: 9a. Total bilirubin ≤ 1.5 X ULN 9b. AST (SGOT) ≤ 5 X ULN 9c. ALT (SGPT) ≤ 5 X ULN Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage.
- 10. Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula.
- 11. Partial thromboplastin time (PTT) < 1.2 x ULN and INR ≤ 1.5 x ULN, if not receiving anticoagulation therapy. For patients receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use.
- 12. Subject must have no clinically significant abnormalities in urinalysis results (obtained ≤ 14 days prior to starting Cycle 1 Day 1).
- 13. Ability to understand the nature of this study protocol and give written informed consent. 14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Patients who meet any one of the following criteria will be excluded from this study.
- Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas.
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study.
- Presence of central nervous system metastases.
- Life expectancy < 12 weeks.
- Pregnancy (positive pregnancy test) or lactation.
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- Pre-existing sensory neuropathy > grade 1.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
- Major surgery without complete recovery in the past 4 weeks prior to screening.
- Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
- Concurrent active infection.
- Patient with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C.
- Patient who has a history of allergy or hypersensitivity to any of the study drugs.
- Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
RWJBarnabas Health - Jersey City Medical Center, Jersey City
Jersey City, New Jersey, 07302
RWJBarnabas Health - Saint Barnabas Medical Center, Livingston
Livingston, New Jersey, 07039
Monmouth Medical Center
Long Branch, New Jersey, 07740
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerset, New Jersey, 08873
About this study
Official title: Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel in Untreated Metastatic Adenocarcinoma of the Pancreas
The main objective of the clinical trial is to determine if modified FOLFIRINOX (mFFX) alternated with biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP) administered as a combined, front-line therapy will result in longer time to treatment failure (TTF) compared to the current standard of care with mFFX alone in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Read the detailed description
- Primary objective: To determine whether mFFX and mGnabP administered as a combined, alternating, front-line therapy can provide longer first line treatment for patients with metastatic pancreatic cancer, with the primary metric of time to treatment failure (TTF), including progression of disease (PD), death or treatment discontinuation due to toxicity.
- Primary endpoint: TTF (treatment discontinuation due to toxicity, disease progression, or death).
- Secondary objectives:
- To determine objective response rate (ORR) of the regimen. 2) To determine progression-free survival (PFS) rate of the regimen. 3) To determine overall survival (OS) rate of the regimen. 4) To assess biomarker response (CA-19.9) to the regimen. 5) To examine safety and tolerability of the new regimen. 6) To examine health-related quality of life in patients receiving this regimen.
- Secondary endpoints:
- ORR as determined by the proportion of subjects with either complete response (CR) or partial response (PR), as defined by RECIST 1.1.
- PFS as determined by the time interval from the date of first dose of study regimen to first documented PD or death from any cause, whichever occurs first.
- Overall survival (OS) as defined as the time interval from the date of the first dose of study regimen to date of death from any cause.
- Biomarker response, measured by serum CA 19-9 levels every 4 weeks.
- Safety and tolerability of the mFFX alternating with mGnabP regimen; Grade 3 and 4 toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Follow up for toxicity will be recorded for the first 30 days following the last chemotherapy cycle, and any long-term toxicity will be followed for up to 2 years after completion of study therapy.
- Exploratory objectives:
- To determine the tumor molecular profile prior to initiation of chemotherapy and correlate with treatment response.
- To analyze ct-DNA as a biomarker of response to therapy and early detection of disease progression.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Folfirinox alternating with 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.
Folfirinox alternating with Gemcitabine-nab-PaclitaxelDrug
Also called Oxaliplatin, Leucovorin, Irinotecan, Nab-Paclitaxel
modified Folfirinox every 2 weeks and biweekly Gemcitabine plus Nab-Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen: mFOLFIRINOX + mGnabP | Experimental | All study participants will receive the following treatment:
mFOLFIRINOX (28-day cycle)
Day 1 and Day 15:
Oxaliplatin 85 mg/m2 2-hour intravenous infusion followed by leucovorin 400 mg/m2 2-hour infusions with the addition of irinotecan 150 mg/m2 as a 90 minute infusion. 5-FU 2400 mg/m2 continuous intravenous infusion over 46 hours will follow irinotecan.
Day 3 and Day 17:
Pegylated-Granulocyte Colony Stimulating Facotr (peg-GCSF) 6 mg subcutaneous injection following disconnection of 5-FU infusion, first cycle and then per investigator discretion.
Biweekly mGnabP (28-day cycle)
Day 1 and Day 15:
Nab-paclitaxel 125 mg/m2 infused over 30 minutes, immediately followed by Gemcitabine 1200 mg/m2 intravenously infused at the rate of 10mg/m2/min (over 120 minutes).
Patients will receive one month of each regimen, alternately monthly until progression of disease. Receives: Drug: Folfirinox alternating with Gemcitabine-nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF)
The primary objective of this study is to determine time to treatment failure (TTF) in patients with metastatic pancreatic cancer treated in front line setting with mFOLFIRINOX (mFFX) alternating with biweekly Gemcitabine and nab-Paclitaxel (mGnabP).
Measured: 24 weeks
Secondary outcomes (6)
Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1 by independent radiology review) at 8 week intervals.
Measured: 24 weeks
Progression-free survival (PFS)
To determine progression-free survival (PFS) rate of the regimen.
Measured: 24 weeks
Overall survival (OS)
To determine overall survival (OS) rate of the regimen.
Measured: 24 weeks
Safety and tolerability assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Safety and tolerability of the mFFX alternating with mGnabP regimen; Grade 3 and 4 toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Follow up for toxicity will be recorded for the first 30 days following the last chemotherapy cycle, and any long-term toxicity will be followed for up to 2 years after completion of study therapy.
Measured: 24 weeks
EORTC QLQ-CIPN20 questionnaire
Patient reported outcomes, examined through the EORTC QLQ-CIPN20 questionnaire
Measured: Administered at baseline prior to start of therapy, then every 8 weeks while receiving therapy, and at the end of treatment, average of 1 year
Correlation between variation in variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy
Correlation between variation in the variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy
Measured: Assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start6 Jan 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- single group assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lyudmyla Berim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lyudmyla Berim, Rutgers, The State University of New Jersey
- Investigators
- Lyudmyla Berim, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672005
- Sponsor's protocol ID
- Pro2020002395
- Other IDs
- 072011
- Status last verified
- May 2024
- First submitted
- 9 Nov 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel in Untreated Metastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT04672005
- Acronym / sponsor ID
- Pro2020002395
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lyudmyla BerimUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 17 Dec 2020 (actual)
- 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 main objective of the clinical trial is to determine if modified FOLFIRINOX (mFFX) alternated with biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP) administered as a combined, front-line therapy will result in longer time to treatment failure (TTF) compared to the current standard of care with mFFX alone in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Detailed description
- Primary objective: To determine whether mFFX and mGnabP administered as a combined, alternating, front-line therapy can provide longer first line treatment for patients with metastatic pancreatic cancer, with the primary metric of time to treatment failure (TTF), including progression of disease (PD), death or treatment discontinuation due to toxicity.
- Primary endpoint: TTF (treatment discontinuation due to toxicity, disease progression, or death).
- Secondary objectives:
- To determine objective response rate (ORR) of the regimen. 2) To determine progression-free survival (PFS) rate of the regimen. 3) To determine overall survival (OS) rate of the regimen. 4) To assess biomarker response (CA-19.9) to the regimen. 5) To examine safety and tolerability of the new regimen. 6) To examine health-related quality of life in patients receiving this regimen.
- Secondary endpoints:
- ORR as determined by the proportion of subjects with either complete response (CR) or partial response (PR), as defined by RECIST 1.1.
- PFS as determined by the time interval from the date of first dose of study regimen to first documented PD or death from any cause, whichever occurs first.
- Overall survival (OS) as defined as the time interval from the date of the first dose of study regimen to date of death from any cause.
- Biomarker response, measured by serum CA 19-9 levels every 4 weeks.
- Safety and tolerability of the mFFX alternating with mGnabP regimen; Grade 3 and 4 toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Follow up for toxicity will be recorded for the first 30 days following the last chemotherapy cycle, and any long-term toxicity will be followed for up to 2 years after completion of study therapy.
- Exploratory objectives:
- To determine the tumor molecular profile prior to initiation of chemotherapy and correlate with treatment response.
- To analyze ct-DNA as a biomarker of response to therapy and early detection of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment Regimen: mFOLFIRINOX + mGnabP | Experimental | Drug: Folfirinox alternating with Gemcitabine-nab-PaclitaxelAll study participants will receive the following treatment: mFOLFIRINOX (28-day cycle) Day 1 and Day 15: Oxaliplatin 85 mg/m2 2-hour intravenous infusion followed by leucovorin 400 mg/m2 2-hour infusions with the addition of irinotecan 150 mg/m2 as a 90 minute infusion. 5-FU 2400 mg/m2 continuous intravenous infusion over 46 hours will follow irinotecan. Day 3 and Day 17: Pegylated-Granulocyte Colony Stimulating Facotr (peg-GCSF) 6 mg subcutaneous injection following disconnection of 5-FU infusion, first cycle and then per investigator discretion. Biweekly mGnabP (28-day cycle) Day 1 and Day 15: Nab-paclitaxel 125 mg/m2 infused over 30 minutes, immediately followed by Gemcitabine 1200 mg/m2 intravenously infused at the rate of 10mg/m2/min (over 120 minutes). Patients will receive one month of each regimen, alternately monthly until progression of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically and/or cytologically confirmed pancreatic adenocarcinoma.
- Stage IV disease. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data.
- Subject must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a subject received prior neoadjuvant or adjuvant chemotherapy, tumor recurrence must have occurred more than 6 months after completing the last dose of chemotherapy.
- ECOG performance status of 0-1.
- At least 18 years of age.
Key exclusion criteria (15 listed)
- Patients who meet any one of the following criteria will be excluded from this study.
- Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas.
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study.
- Presence of central nervous system metastases.
- Life expectancy < 12 weeks.
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 |
|---|---|---|
| Folfirinox alternating with Gemcitabine-nab-PaclitaxelAlso: Oxaliplatin, Leucovorin, Irinotecan, Nab-Paclitaxelmodified Folfirinox every 2 weeks and biweekly Gemcitabine plus Nab-Paclitaxel | Drug | Treatment Regimen: mFOLFIRINOX + mGnabP |
Primary outcome
Time to treatment failure (TTF)
Time frame: 24 weeks
The primary objective of this study is to determine time to treatment failure (TTF) in patients with metastatic pancreatic cancer treated in front line setting with mFOLFIRINOX (mFFX) alternating with biweekly Gemcitabine and nab-Paclitaxel (mGnabP).
6 secondary outcomes
Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Time frame: 24 weeks
Progression-free survival (PFS)
Time frame: 24 weeks
Overall survival (OS)
Time frame: 24 weeks
Safety and tolerability assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 24 weeks
EORTC QLQ-CIPN20 questionnaire
Time frame: Administered at baseline prior to start of therapy, then every 8 weeks while receiving therapy, and at the end of treatment, average of 1 year
Correlation between variation in variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy
Time frame: Assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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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.
Lyudmyla Berim, MD principal investigator
Rutgers Cancer Institute of New Jersey
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Folfirinox alternating with Gemcitabine-nab-Paclitaxel in people with Metastatic Pancreatic Cancer, run by Lyudmyla Berim at 7 sites 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 13 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Time to treatment failure (TTF) (time frame: 24 weeks). 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 16 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.