Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer

September 16, 2020 updated by: Hani Ashamalla, MD, New York Presbyterian Brooklyn Methodist Hospital

A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer

The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.

Study Type

Interventional

Phase

  • 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
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital

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:

  1. Pathologically confirmed adenocarcinoma of the pancreas.
  2. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
  3. Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible.
  4. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
  5. All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum).
  6. All patients must have radiographically assessable disease.
  7. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  9. Required entry laboratory parameters: granulocytes >/= 1,800/µl, platelet count >/= 100,000/µl, bilirubin < 2.0 mg/dL, alanine aminotransferase (ALT) < 3 x upper limit of normal, and creatinine < 3.0 mg/dL.
  10. Signed study-specific consent form prior to study entry.

Exclusion Criteria:

  1. Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
  2. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
  3. Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
  4. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paclitaxel and Gemcitabine

Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.

Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
Drug: Paclitaxel and gemcitabine

Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.

Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year overall survival rate
Time Frame: Up to June 2010
Follow up for survival will be done to know this outcome
Up to June 2010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
Time Frame: year 2010
Follow up for occurrence of adverse events will be done to know this outcome
year 2010
Occurrence of pathological response or shrinkage of the tumor (becomes resectable)
Time Frame: year 2010
Follow up for tumor response will be done to know this outcome
year 2010

Collaborators and Investigators

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

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

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 (ACTUAL)

March 1, 2003

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (ESTIMATE)

September 27, 2005

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYM # 179; AM-05

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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