- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02207465
A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
November 3, 2023 updated by: Abramson Cancer Center at Penn Medicine
The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer.
We propose to do this by combining nab-paclitaxel concurrently with dose-escalated radiation therapy.
In the first part of this phase I study (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held constant at a standardly accepted level.
The use of this novel chemoradiotherapy regimen will take advantage of nab-paclitaxel's specific anti-tumor and anti-stromal properties, which may enhance the efficacy of radiation therapy, and thereby improve local control.
After the MTD of nab-paclitaxel had been determined, a second arm in sub-trial 1 will evaluate the addition of paricalcitol to nab-paclitaxel concurrently with dose-escalated radiation therapy.
In addition, after the MTD of the nab-paclitaxel is reached in sub-trial 1 arm A, in the second part of this study (sub-trial 2), we will administer nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation.
We will utilize IMRT or protons to safely deliver high doses of radiation while maximally sparing surrounding normal tissue.
Patients will also preferentially have 2-3 fiducial markers placed in or around the tumor for daily localization.
Chemotherapy before and/or after chemoradiotherapy may be given as per standard of care.
Correlative tissue and serum biomarkers are an important, but optional, part of this study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edgar Ben-Josef, MD
- Phone Number: 215-662-6567
- Email: Edgar.Ben-Josef@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Abramson Cancer Center of the University of Pennsylvania
-
Principal Investigator:
- Edgar Ben-Josef, MD
-
Contact:
- Taylor Siegal
- Phone Number: 610-233-6747
- Email: taylor.siegal@pennmedicine.upenn.edu
-
West Chester, Pennsylvania, United States, 19380
- Recruiting
- Chester County Hospital
-
Contact:
- CarolAnn Hoppes, RN, MSN
- Phone Number: 610-431-5044
- Email: CarolAnn.Hoppes@pennmedicine.upenn.edu
-
Principal Investigator:
- Andre Konski, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas.
- Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014):
Unresectable
- Greater than 180 degrees of SMA encasement
- Any celiac abutment
- Unreconstructible SMV/portal occlusion
- Aortic invasion or encasement
- Nodal metastases beyond the field of resection Borderline resectable
- Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen
- Encasement of the SMV/portal vein but without encasement of the nearby arteries
- Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting.
- Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis
- Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall
- Age > 18 years.
- ECOG performance status of ≤ 1.
- Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST < 5 times the upper limit of normal.
- Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial.
- Patients must be able to provide written informed consent.
Exclusion Criteria:
- Distant metastatic disease.
- Prior history of abdominal radiation therapy.
- Prior systemic therapy for pancreatic cancer.
- Prior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer). In-situ carcinoma is allowed.
- Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
- Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study.
- Pregnant women, women planning to become pregnant and women that are nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subtrial 1-Arm A (Dose Level 1 of Abraxane)
Determine if it is safe or not (via occurrence of dose limiting toxicities) for patients to receive both Abraxane and radiation therapy.
|
Dose varies within subtrial 1 to determine maximum dose.
All patients in subtrial 2 receive 125mg Abraxane
Other Names:
|
Experimental: Subtrial 1-Arm B (Dose Level 2 of Abraxane: 3+4 enrollment)
Determine the maximum dose of Abraxane that is allowable and safe for patients receiving both Abraxane and radiation therapy.
|
Dose varies within subtrial 1 to determine maximum dose.
All patients in subtrial 2 receive 125mg Abraxane
Other Names:
|
Experimental: Subtrial 2- Abraxane 125mg; Borderline get 55cGY, unresectable get 57.5cGY until next escalation
|
Dose varies within subtrial 1 to determine maximum dose.
All patients in subtrial 2 receive 125mg Abraxane
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Adverse Events
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edgar Ben-Josef, MD, Abramson Cancer Center at Penn Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 31, 2014
First Submitted That Met QC Criteria
August 1, 2014
First Posted (Estimated)
August 4, 2014
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 3, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- UPCC 32213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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