Locally Advanced Unresectable Pancreatic Cancer Treated With ChemoradiotherapyPhase 1NCT02207465
A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
A Phase 1 study testing Radiotherapy and Abraxane in people with Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy and Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy, Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy
- What is being tested?
- Radiotherapy and Abraxane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Dec 2026
- Phase
- Phase 1
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 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
Show all 18Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Chester County Hospital
West Chester, Pennsylvania, 19380
About this study
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.
- Conditions
- Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy, Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy
- Being tested
- Radiotherapy, Abraxane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
AbraxaneDrug
Also called nab-paclitaxel
Dose varies within subtrial 1 to determine maximum dose. All patients in subtrial 2 receive 125mg Abraxane
| Study group | Role | What they receive |
|---|---|---|
| Subtrial 1-Arm A (Dose Level 1 of Abraxane) | Experimental | Determine if it is safe or not (via occurrence of dose limiting toxicities) for patients to receive both Abraxane and radiation therapy. Receives: Radiation: Radiotherapy; Drug: Abraxane |
| Subtrial 1-Arm B (Dose Level 2 of Abraxane: 3+4 enrollment) | Experimental | Determine the maximum dose of Abraxane that is allowable and safe for patients receiving both Abraxane and radiation therapy. Receives: Radiation: Radiotherapy; Drug: Abraxane |
| Subtrial 2- Abraxane 125mg; Borderline get 55cGY, unresectable get 57.5cGY until next escalation | Experimental | Not described Receives: Radiation: Radiotherapy; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable Pancreatic Cancer Treated With ChemoradiotherapyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edgar Ben-Josef, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207465
- Sponsor's protocol ID
- UPCC 32213
- Status last verified
- Nov 2025
- First submitted
- 31 Jul 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes