search
Back to results

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

Primary Purpose

Carcinoma, Pancreatic Ductal

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel and gemcitabine
Sponsored by
New York Presbyterian Brooklyn Methodist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Pancreatic Ductal focused on measuring Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal

Eligibility Criteria

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

Inclusion Criteria: Pathologically confirmed adenocarcinoma of the pancreas. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability. Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation. All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum). All patients must have radiographically assessable disease. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 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. Signed study-specific consent form prior to study entry. Exclusion Criteria: Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®). Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.

Sites / Locations

  • New York Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel and Gemcitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

One-year overall survival rate
Follow up for survival will be done to know this outcome

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2005
Last Updated
September 16, 2020
Sponsor
New York Presbyterian Brooklyn Methodist Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00226746
Brief Title
Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
Official Title
A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Study Start Date
March 2003 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Brooklyn Methodist Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal
Keywords
Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Radiation Therapy: 63.80 Gy (1.1 Gy BID 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel and Gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and gemcitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
One-year overall survival rate
Description
Follow up for survival will be done to know this outcome
Time Frame
Up to June 2010
Secondary Outcome Measure Information:
Title
Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
Description
Follow up for occurrence of adverse events will be done to know this outcome
Time Frame
year 2010
Title
Occurrence of pathological response or shrinkage of the tumor (becomes resectable)
Description
Follow up for tumor response will be done to know this outcome
Time Frame
year 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed adenocarcinoma of the pancreas. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability. Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation. All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum). All patients must have radiographically assessable disease. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 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. Signed study-specific consent form prior to study entry. Exclusion Criteria: Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®). Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hani Ashamalla, MD, FCCP
Organizational Affiliation
New York Presbyterian Brooklyn Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12573755
Citation
Ashamalla H, Zaki B, Mokhtar B, Colella F, Selim H, Krishnamurthy M, Ross P. Hyperfractionated radiotherapy and paclitaxel for locally advanced/unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):679-87. doi: 10.1016/s0360-3016(02)03791-4. Erratum In: Int J Radiat Oncol Biol Phys. 2003 Mar 15;55(4):1158.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs