Locally Advanced Pancreatic CancerEarly Phase 1NCT03600623
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
A Early Phase 1 study testing Folfirinox and Gemcitabine nab-Paclitaxel in people with Locally Advanced Pancreatic Cancer and Borderline Pancreatic Inoperable Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Borderline Pancreatic Inoperable Cancer, Pancreatic Cancer
- What is being tested?
- Folfirinox and Gemcitabine nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 31 Jul 2020
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
- Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, being eligible; and have a primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or body/tail)
- The tumor must be deemed as being borderline/unresectable. Final CT confirmation of surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of the patient.
- Disease must be confined to loco-regional site as confirmed by CT imaging and/or diagnostic staging laparoscopy to avoid occult peritoneal deposits. Diagnostic laparoscopy will be performed only if absolutely required
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
- Karnofsky performance status greater than or equal to 70 or Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
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- Age >18
- Estimated life expectance >12 weeks
- If female patient is of child bearing potential, she must have a negative serum pregnancy test (βhCG) documented up to 72 hrs prior to administration of first study drug
- Patient has screening blood work performed which includes the following (should be drawn ≤14 days prior to enrollment)
- Absolute neutrophil count (ANC) >1.5 x 109/L
- Platelet count ≥100,000/mm3
- Hemoglobin (Hgb) ≥ 9g/dL
- Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) Total Bilirubin ≤1.5 ULN
- Serum Cr within normal limits (WNL)
- Prothrombin Time and International Normalized Ratio (PT/INR) and Partial Thromboplastin Time (PTT) within normal limits (±15%).
- Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist
Who cannot join
- Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
- Patients must not have received prior pancreatic surgery, radiation therapy, chemotherapy or any investigational therapy for pancreatic cancer.
- Patients with tumors extending or invading duodenum or gastric are not eligible.
- Evidence of distant metastasis on upright chest x-ray, CT or other staging studies
- Subjects with recurrent disease are not eligible
- Prior radiation therapy to the upper abdomen or liver at the discretion of the treating radiation oncologist could impair delivery of the prescribed radiation treatment
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- Patients with scleroderma, ulcerative colitis or other systemic conditions deemed risky for radiation treatment. Therefore, will be excluded.
- Prior chemotherapy
- Subjects in their reproductive age who are breast feeding or have a positive pregnancy test
- Any co-morbid condition such as but not limited to congestive heart failure, cardiac arrhythmia or psychiatric illness of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician
- Concurrent active infection
- No prior malignancy allowed except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer
- Patient with known historical or active infection with HIV, Hepatitis B or Hepatitis C
- Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to enrollment.
- 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 or multiple allergies
- Patients with greater than grade 2 peripheral neuropathy at the time of enrollment are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Neoadjuvant Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer
This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). While the chemotherapy is standard of care, the strategy of adding SBRT has not been investigated. An increase in the percentage of patients who can proceed to have surgery to remove their disease is anticipated with this approach.
Read the detailed description
This pilot study will evaluate safety and tolerability of neoadjuvant chemotherapy followed by SBRT. Patients with locally advanced pancreatic cancer (LAPC) and borderline pancreatic inoperable cancer will be assigned to one of two treatment arms based upon performance status and physician's discretion. The two treatment arms are: Folfirinox or gemcitabine-nab paclitaxel (abraxane). There are no study drugs as all treatments are based on standard clinical pathways.
After two cycles of treatment patients will be restaged with CT scans or imaging. If the tumor remains resectable, borderline, or unresectable without progression of disease, then the patient will proceed to SBRT.
Follow-up visits will continue every three months for up to one year or until progression of disease.
- Conditions
- Locally Advanced Pancreatic Cancer, Borderline Pancreatic Inoperable Cancer, Pancreatic Cancer
- Being tested
- Folfirinox, Gemcitabine nab-Paclitaxel
- Keywords
- advanced pancreatic cancer, inoperable pancreatic cancer, Folfirinox, Gemcitabine-Abraxane, Gemcitabine-nab-Paclitaxel, Stereotactic Body Radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolfirinoxDrug
Also called Folfirinox = Fluorouracil + Folinic Acid + Oxaliplatin + Irinotecan
SBRT will follow Folfirinox at the completion of Cycle 2 (if eligible).
Gemcitabine nab-PaclitaxelDrug
Also called Paclitaxel = Abraxane
SBRT will follow Gemcitabine nab-Paclitaxel at the completion of Cycle 2 (if eligible).
| Study group | Role | What they receive |
|---|---|---|
| Folfirinox + SBRT | Experimental | Folfirinox comprises the following: Fluorouracil 2,400 mg/m2 intravenously over 48 hours Days 1-3 and 15-17 every 4 weeks; Folinic acid 400 mg intravenously on Days 1 and 15 every 4 weeks; Oxaliplatin 85 mg/m2 intravenously on Days 1 and 15 every 4 weeks; and Irinotecan 180 mg/m2 intravenously on Days 1 and 15 every 4 weeks. Radiation will begin at the completion of cycle 2 if chemotherapy toxicity permits and will last over a period of 5 days. Receives: Drug: Folfirinox |
| Gemcitabine-nab Paclitaxel + SBRT | Experimental | Gemcitabine-nab Paclitaxel comprises the following: Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 every 4 weeks; nab Paclitaxel 125 mg/m2 on Days 1, 8, and 15 every 4 weeks. Radiation will begin at the completion of cycle 2 if chemotherapy toxicity permits and will last over a period of 5 days. Receives: Drug: Gemcitabine nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Initial dose of drug until 4 weeks following completion of therapy which may or may not include SBRT and follow-up. Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Measured: Baseline up to two years
Secondary outcomes (4)
Progression-free survival
Progression-free survival is the duration of time from study entry to time of disease progression or death, whichever comes first.
Measured: Baseline up to two years
Overall survival
Overall survival is the duration of time from study entry to time of death or the date of last contact.
Measured: Baseline to two years
Rate of preoperative chemotherapy + radiotherapy completion
The rate will be determined from the measurement of lesions (maximum of 2 per organ with no more than 5 lesions total) from CT scans and magnetic resonance imaging within the study time frame.
Measured: Baseline to two years
Proportion of participants undergoing surgery after preoperative chemoradiation therapy
Comparison of participants who underwent surgery versus those that did not following preoperative chemoradiation therapy
Measured: Baseline to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start25 Sep 2017
- Primary completion30 Jul 2020
- Study completion31 Jul 2020
Why it stopped: PI left the institution; no further accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to one of two treatment arms: Arm 1 is Folfirinox (5FU/Leucovorin/Irinotecan/Oxaliplatin) and Arm 2 is Gemcitabine-nab-Paclitaxel (Abraxane). Either arm will be followed with SBRT for eligible patients.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravi Kumar Paluri, University of Alabama at Birmingham
- Investigators
- Ravi K Paluri, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600623
- Sponsor's protocol ID
- IRB160830003 (UAB 1632)
- Status last verified
- Aug 2020
- First submitted
- 17 Jul 2018
- Last updated
- 18 Aug 2020
- 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 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03600623
- Acronym / sponsor ID
- IRB160830003 (UAB 1632)
- Conditions
- Locally Advanced Pancreatic Cancer, Borderline Pancreatic Inoperable Cancer, Pancreatic Cancer
- Keywords
- advanced pancreatic cancer, inoperable pancreatic cancer, Folfirinox, Gemcitabine-Abraxane, Gemcitabine-nab-Paclitaxel, Stereotactic Body Radiotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution; no further accruals
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 26 Jul 2018 (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.
This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). While the chemotherapy is standard of care, the strategy of adding SBRT has not been investigated. An increase in the percentage of patients who can proceed to have surgery to remove their disease is anticipated with this approach.
Detailed description
This pilot study will evaluate safety and tolerability of neoadjuvant chemotherapy followed by SBRT. Patients with locally advanced pancreatic cancer (LAPC) and borderline pancreatic inoperable cancer will be assigned to one of two treatment arms based upon performance status and physician's discretion. The two treatment arms are: Folfirinox or gemcitabine-nab paclitaxel (abraxane). There are no study drugs as all treatments are based on standard clinical pathways.
After two cycles of treatment patients will be restaged with CT scans or imaging. If the tumor remains resectable, borderline, or unresectable without progression of disease, then the patient will proceed to SBRT.
Follow-up visits will continue every three months for up to one year or until progression of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to one of two treatment arms: Arm 1 is Folfirinox (5FU/Leucovorin/Irinotecan/Oxaliplatin) and Arm 2 is Gemcitabine-nab-Paclitaxel (Abraxane). Either arm will be followed with SBRT for eligible patients.
| Arm | Type | Receives |
|---|---|---|
| Folfirinox + SBRT | Experimental | Drug: FolfirinoxFolfirinox comprises the following: Fluorouracil 2,400 mg/m2 intravenously over 48 hours Days 1-3 and 15-17 every 4 weeks; Folinic acid 400 mg intravenously on Days 1 and 15 every 4 weeks; Oxaliplatin 85 mg/m2 intravenously on Days 1 and 15 every 4 weeks; and Irinotecan 180 mg/m2 intravenously on Days 1 and 15 every 4 weeks. Radiation will begin at the completion of cycle 2 if chemotherapy toxicity permits and will last over a period of 5 days. |
| Gemcitabine-nab Paclitaxel + SBRT | Experimental | Drug: Gemcitabine nab-PaclitaxelGemcitabine-nab Paclitaxel comprises the following: Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 every 4 weeks; nab Paclitaxel 125 mg/m2 on Days 1, 8, and 15 every 4 weeks. Radiation will begin at the completion of cycle 2 if chemotherapy toxicity permits and will last over a period of 5 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
- Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, being eligible; and have a primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or body/tail)
- The tumor must be deemed as being borderline/unresectable. Final CT confirmation of surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of the patient.
- Disease must be confined to loco-regional site as confirmed by CT imaging and/or diagnostic staging laparoscopy to avoid occult peritoneal deposits. Diagnostic laparoscopy will be performed only if absolutely required
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
Key exclusion criteria (17 listed)
- Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
- Patients must not have received prior pancreatic surgery, radiation therapy, chemotherapy or any investigational therapy for pancreatic cancer.
- Patients with tumors extending or invading duodenum or gastric are not eligible.
- Evidence of distant metastasis on upright chest x-ray, CT or other staging studies
- Subjects with recurrent disease are not eligible
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 |
|---|---|---|
| FolfirinoxAlso: Folfirinox = Fluorouracil + Folinic Acid + Oxaliplatin + IrinotecanSBRT will follow Folfirinox at the completion of Cycle 2 (if eligible). | Drug | Folfirinox + SBRT |
| Gemcitabine nab-PaclitaxelAlso: Paclitaxel = AbraxaneSBRT will follow Gemcitabine nab-Paclitaxel at the completion of Cycle 2 (if eligible). | Drug | Gemcitabine-nab Paclitaxel + SBRT |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Baseline up to two years
Initial dose of drug until 4 weeks following completion of therapy which may or may not include SBRT and follow-up. Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
4 secondary outcomes
Progression-free survival
Time frame: Baseline up to two years
Overall survival
Time frame: Baseline to two years
Rate of preoperative chemotherapy + radiotherapy completion
Time frame: Baseline to two years
Proportion of participants undergoing surgery after preoperative chemoradiation therapy
Time frame: Baseline to two years
Results and safety
The study was stopped early (reason given: PI left the institution; no further accruals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- 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.
Ravi K Paluri, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Folfirinox and Gemcitabine nab-Paclitaxel in people with Locally Advanced Pancreatic Cancer and Borderline Pancreatic Inoperable Cancer, run by University of Alabama at Birmingham 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 17 inclusion and 17 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 18 Aug 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: PI left the institution; no further accruals). 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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: Baseline up to two 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 18 Aug 2020.