Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

January 27, 2014 updated by: William Sherman, Columbia University

Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma

This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 2
  • Phase 3

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
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Sherman, MD
        • Sub-Investigator:
          • John Allendorf, MD
        • Sub-Investigator:
          • John Chabot, MD
        • Sub-Investigator:
          • Beth Schrope, MD
        • Sub-Investigator:
          • Kyung Chu, NP
        • Sub-Investigator:
          • Robert Fine, MD

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.)
  • Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
  • No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
  • Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both)
  • No prior chemotherapy or radiation therapy.
  • Ineligible for other high priority national or institutional studies.
  • Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females.
  • Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy.
  • Complete Blood Count and Complete Metabolic Profile:

Absolute Neutrophil Count > 1,500 μl White Blood Count > 3,000/μl Platelet count > 100,000/μl BUN < 1.5 x normal Creatinine < 1.5 normal Hemoglobin > 8.0 g/dl Serum Albumin > 3 mg/dl Total Bilirubin < 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase < 2.5 x ULN

  • Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group I
Patients with only venous involvement Treated with 6 cycles og GTX and then surgery
Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel

6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off.

Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner.

Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment.

Other Names:
  • Taxotere
  • Gemzar
  • Xeloda
EXPERIMENTAL: Group II
Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery
Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy

6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off.

Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner.

Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment.

Radiotherapy should start 2 to 3 weeks after last planned dose of GTX. Gemcitabine at 750mg/M2 days 5, 12, 26, 33 along with capecitabine 1000 mg bid for 5 days darbepoetin 200ug, every 2 weeks if the hemoglobin is less than 10.5 gms/dl while undergoing radiotherapy.

Pegfiligastrim 6mg at the end of week 2 if the WBC count is less than 2500 cells/cu mm.

Other Names:
  • Taxotere
  • Gemzar
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Columbia University

Investigators

  • Principal Investigator: William Sherman, MD, Columbia University

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.

General Publications

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

December 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (ESTIMATE)

February 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAD6491

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.

Clinical Trials on Pancreatic Cancer Stage III

Clinical Trials on Neoadjuvant gemcitabine, capecitabine, and docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe