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

Primary Purpose

Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine

nab-paclitaxel

CyberKnife

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Gemcitabine, Gemzar, CyberKnife, Cyber knife, CK, abraxane, nab-paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

MD Anderson Cancer Center at Cooper

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerable dose

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

Secondary Outcome Measures

overall survival

Tumor response per RECIST 1.1

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

quality of life

Full Information

NCT ID

NCT02707328

First Posted

October 2, 2015

Last Updated

July 26, 2019

Sponsor

The Cooper Health System

1. Study Identification

Unique Protocol Identification Number

NCT02707328

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

Closed after being on administrative hold

Study Start Date

January 2015 (undefined)

Primary Completion Date

November 10, 2017 (Actual)

Study Completion Date

November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cooper Health System

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

The purpose of this study is to determine the MTD for radiosurgery in the treatment of unresectable pancreas cancer, this MTD can then be used in future phase II or III studies. In terms of starting dose for the phase I study, based on the low toxicity seen in the Moffitt study we feel that 30 Gy in five fractions will be a successful starting dose. Most of the data in unresectable is derived from patients in the metastatic setting in terms of chemotherapy agents. There have been two major studies that looked at various chemotherapy regimens versus the previous standard of care Gemzar. One study found improved survival with FOLFIRINOX and a second found that the combination of nab-paclitaxel and gemzar were superior to gemzar alone. Thus, the current standard of care for metastatic pancreas cancer (in which a local therapy like radiation has more limited role) is either FOLFIRINOX or gemzar and nab-paclitaxel. While there is some discussion of a randomized study comparing FOLFIRINOX and gemzar combined with nab-paclitaxel such a study has not started as of this time and it is unclear how much interest there would be in accruing to this study. Therefore the exact best chemotherapy regimen for metastatic disease is unclear but is either FOLFIRIONX or gemzar-nab-paclitaxel. The chemotherapy regimens for unresectable cancer are extrapolated from the metastatic setting, per NCCN guidelines any chemotherapy regimen approved for metastatic disease is reasonable to use in unresectable pancreas cancer. Thus for purpose of this study we have chosen one of the two chemotherapy regimens that have shown the best results in the metastatic setting, since there is no way to determine the exact best regimen we have chosen gemzar and nab-paclitaxel since it is felt that this is a less toxic regimen as compared to FOLFIRINOX.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

gemzar

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Other Intervention Name(s)

abraxane

Intervention Type

Radiation

Intervention Name(s)

CyberKnife

Other Intervention Name(s)

cyber knife, CK, Stereotactic radiosurgery

Primary Outcome Measure Information:

Title

Maximum tolerable dose

Description

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

Time Frame

4-7 months

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

6 months, 1 year, 5 years

Title

Tumor response per RECIST 1.1

Time Frame

4 months, 6 months, 1 year

Title

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

Time Frame

2 months, 6 months, 1 year

Title

quality of life

Time Frame

2 months, 4 months, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

MD Anderson Cancer Center at Cooper

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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