Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery

September 8, 2017 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer

The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Cycle 1 and 2:

    • Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m^2 intravenous piggy back (IVPB) over 30 min
    • Days 4, 11 and 25, 32 ....docetaxel 30 mg/m^2 IVPB over 1 hour
    • Days 1-14 and 22-35 ....capecitabine 750 mg/m^2 oral twice daily
    • Each cycle is 21 days long
  • SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume

  • Cycle 3 and 4:

    • Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min
    • Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour
    • Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily
    • Each cycle is 21 days long
  • Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:

    • circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over < 180o.
    • circumferential tumor abutment with the superior mesenteric artery (SMA) over < 180o.
    • Short segment encasement (360o) of the PV or SMV that is amenable to partial vein resection and reconstruction.
    • encasement of the gastroduodenal artery up to the origin of the hepatic artery
  • Patients must have measurable disease.
  • No previous chemotherapy or radiation to the pancreas.
  • Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%.

  • Patients must have normal organ and marrow function as defined below:

    • leukocytes >3,000/μL
    • absolute neutrophil count >1,000/μL
    • platelets >100,000/μL
    • creatinine within normal institutional limits - OR - creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
    • total bilirubin < institutional upper limit of normal (ULN). Patients may have biliary stents or drains to lower total bilirubin to this range.
    • Aspartate Aminotransferase (AST) serum glutamic oxaloacetic transaminase(SGOT) / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase(SGPT) AST and ALT may be up to 2.5 times ULN if alkaline phosphatase < ULN; or alkaline phosphatase may be up to 4 times ULN if AST and ALT are < ULN.
  • Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients with metastatic disease are ineligible. Patients who have had prior chemotherapy for pancreatic adenocarcinoma.
  • Patients who have received prior radiation to an abdominal site are not eligible.
  • Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell or in-situ cervical cancer.
  • Patients with peripheral neuropathy > grade 2.
  • Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine.
  • Patients may not be receiving any other investigational agents.
  • ECOG PS 3-4
  • Pregnant women are excluded from this study because gemcitabine, capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • creatinine clearance < 30 ml/min (Cockcroft-Gault method).
  • Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chemotherapy followed by Radiation Treatment
GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)
Drug: GTX (gemcitabine, docetaxel and capecitabine)
GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
Other Names:
  • Gemcitabine
  • Taxotere®
  • capecitabine
  • docetaxel
  • Xeloda®
Radiation: stereotactic body radiation therapy
stereotactic body radiation therapy (SBRT) 25
Other Names:
  • SBRT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Resectability
Time Frame: 6 months per patient
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
6 months per patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time Frame: 6 months per patient
Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.
6 months per patient
Number of Participants With Objective Response
Time Frame: 6 months per patient
Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.
6 months per patient
Number of Participants With Overall Survival
Time Frame: 6 months per patient
We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.
6 months per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-15587
  • IST 14091 (Other Identifier: Sanofi-Aventis US Inc.)

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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