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A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02207465
Recruitment Status : Suspended (Covid-19)
First Posted : August 4, 2014
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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. The investigators 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-paclitaxels 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, in the second part of this study (sub-trial 2), the investigators will administer nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation. The investigators will utilize a combination of protons and IMRT 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 and will be treated at breath hold in order to prevent tumor movement with normal respiration. Such a technique will help minimize target volumes and thereby avoid critical normal structures. The investigators will use gemcitabine and nab-paclitaxel before and after chemoradiotherapy given its promising results in metastatic pancreatic cancer patients. Correlative tissue and serum biomarkers are an important, but optional, part of this study.

Condition or disease Intervention/treatment Phase
Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy Radiation: Radiotherapy Drug: Gemcitabine 1000 mg Drug: nab-paclitaxel 125 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
Study Start Date : July 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Single Arm Radiation: Radiotherapy
Drug: Gemcitabine 1000 mg
Drug: nab-paclitaxel 125 mg

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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):


  • 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.
  • Patients who are unable to perform the breath hold scan for planning purposes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02207465

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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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Principal Investigator: Edgar Ben-Josef, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT02207465    
Other Study ID Numbers: UPCC 32213
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs