Metastatic Pancreatic CancerPhase 2NCT02080221
BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
A Phase 2 study testing FOLFOXA in people with Metastatic Pancreatic Cancer, run by Brown University at 2 sites in United States.
Trial summary
A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for… 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?
- FOLFOXA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to 16 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
- Metastatic advanced disease.
- No prior chemotherapy for pancreatic cancer
- No major surgery within 3 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. For questions on if a surgery is deemed "major," definition by surgeon can be used for clarification. Laparoscopy and central venous catheter placement are not considered major surgery.
- No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
- ECOG performance status 0 or 1.
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- Age ≥ 18
- Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause or lack of menses >12 months) do not need to have a pregnancy test, please document status.
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. Documentation of this being discussed required.
- Required Initial Laboratory Values:
- Neutrophils ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1.25 x ULN
- AST (SGOT) \& ALT (SGPT) ≤ 2.5 x ULN (for patients with liver metastases, AST\&ALT < 5xULN)
- Alkaline phosphatase < 2.5xULN, unless bone metastasis is present and in the absence of liver metastasis
Who cannot join
- Patients with known brain metastases
- Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed
- Preexisting neuropathy
- Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A 5. Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration.
- 6. Patients with active infection or fever (patients on antibiotics for infection or patients getting over a cold or seasonal virus are not excluded), or known historical or active infection with HIV, hepatitis B, or hepatitis C.
- 7. Patients with sepsis or pneumonitis. 8. Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies that in the investigator's opinion would put the patient at an increased risk.
- 10. Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or uncontrolled) required at registration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southcoast centers for cancer care
Fairhaven, Massachusetts, 02179
Lifespan Hospitals (The Miriam and RI Hospital, East Greenwich, Newport)
Providence, Rhode Island, 02903
About this study
A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®. Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with the other 3 drugs is being investigated. Your doctors are studying the activity and side effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.
Read the detailed description
See summary above
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- FOLFOXA
- Keywords
- metastatic pancreatic cancer, pancreatic cancer, metastatic
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXADrug
Also called 1 cycle = 14 days, Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days., Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days, Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXA | Experimental | 1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) Receives: Drug: FOLFOXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Measured: Every 3 months for up to 5 years
Secondary outcomes (1)
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Measured: Every 3 months for up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startAug 2014
- Primary completion9 Jan 2020
- Study completion16 Mar 2022
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 Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Brown 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Lifespan, SouthCoast Medical Group, Memorial hospital
- Responsible party
- Sponsor
- Investigators
- Howard Safran, MD, Principal investigator, BrUOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080221
- Sponsor's protocol ID
- BrUOG 292
- Status last verified
- Jul 2022
- First submitted
- 3 Mar 2014
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
- ClinicalTrials.gov ID
- NCT02080221
- Acronym / sponsor ID
- BrUOG 292
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- metastatic pancreatic cancer, pancreatic cancer, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Lifespan, SouthCoast Medical Group, Memorial hospital
- Study start
- Aug 2014
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 13 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®. Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with the other 3 drugs is being investigated. Your doctors are studying the activity and side effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.
Detailed description
See summary above
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOXA | Experimental | Drug: FOLFOXA1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
- Metastatic advanced disease.
- No prior chemotherapy for pancreatic cancer
- No major surgery within 3 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. For questions on if a surgery is deemed "major," definition by surgeon can be used for clarification. Laparoscopy and central venous catheter placement are not considered major surgery.
- No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
Key exclusion criteria (7 listed)
- Patients with known brain metastases
- Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed
- Preexisting neuropathy
- Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A 5. Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration.
- 6. Patients with active infection or fever (patients on antibiotics for infection or patients getting over a cold or seasonal virus are not excluded), or known historical or active 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 |
|---|---|---|
| FOLFOXAAlso: 1 cycle = 14 days, Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days., Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days, Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days | Drug | FOLFOXA |
Primary outcome
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Time frame: Every 3 months for up to 5 years
1 secondary outcome
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Time frame: Every 3 months for up to 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- 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.
Howard Safran, MD principal investigator
BrUOG
2 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 FOLFOXA in people with Metastatic Pancreatic Cancer, run by Brown University at 2 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 16 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: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 13 Aug 2021). 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?
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone. (time frame: Every 3 months for up to 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 1 Aug 2022.