Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)

NCT02707328 | Terminated Phase 1

• 1 other identifier: 14-176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable adenocarcinoma of the pancreas.

Conditions

Pancreas Cancer; Pancreatic Cancer; Adenocarcinoma of the Pancreas; Pancreas Adenocarcinoma; Pancreatic Adenocarcinoma

Keywords

Gemcitabine; Gemzar; CyberKnife; Cyber knife; CK; abraxane; nab-paclitaxel

Outcome Measures

Primary Outcomes (1)

• Maximum tolerable dose

  This study is to evaluate the MTD for Cyberknife when given in conjunction with Gemcitabine and Abraxane.

  4-7 months

Secondary Outcomes (4)

• overall survival

  6 months, 1 year, 5 years

• Tumor response per RECIST 1.1

  4 months, 6 months, 1 year

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2 months, 6 months, 1 year

• quality of life

  2 months, 4 months, 6 months, 1 year

Study Arms (1)

A

EXPERIMENTAL

Chemotherapy: Gemcitabine 1000 mg/m2 and Abraxane 125 mg/m2 weekly x3 of 28 day cycle Radiation: 20-55 GY over 5 fractions Dosing schedule: 3 cycles of chemotherapy, followed by CyberKnife, followed by 3 additional cycles of chemotherapy.

Drug: Gemcitabine; Drug: nab-paclitaxel; Radiation: CyberKnife

Interventions

Gemcitabine DRUG

Also known as: gemzar

A

nab-paclitaxel DRUG

Also known as: abraxane

A

CyberKnife RADIATION

Also known as: cyber knife, CK, Stereotactic radiosurgery

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed adenocarcinoma of the pancreas
• Unresectable disease based on the following imaging criteria (table 1)
• extrapancreatic extension
• tumor involvement of the SMA or celiac axis
• evidence of occlusion of the SMV-portal vein confluence
• KPS \> 50 (ECOG 0-2)
• Age \>18 years
• Women of childbearing age and male participants must practice adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and throughout study treatment.
• Life expectancy \> 3 months
• Ability to understand and the willingness to sign a written informed consent.
• Note that patients with metastatic disease are eligible if it is felt that the patients will benefit from local control of the primary disease.
• Disease that is measureable or evaluable for response endpoint per RECIST

You may not qualify if:

• Prior radiotherapy to the upper abdomen
• Resectable or borderline resectable pancreas cancer. Note that these patients are eligible for a separate study looking at radiosurgery for borderline resectable pancreas cancer
• Severe comorbidity rendering a candidate ineligible for chemotherapy or radiation, Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients of childbearing age who are unwilling or unable to practice contraception
• Inability to undergo MRI or CT with contrast for treatment planning
• Patients may not be receiving any other investigational nor commercial agents with therapeutic intent to treat pancreatic cancer while on this trial. Note that patients can have had previous investigational therapy but cannot have this concurrently with this protocol treatment.

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: March 14, 2016
• Study Start: January 1, 2015
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

US (1)