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

Carcinoma, Pancreatic Ductal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00226746
• Other study ID #: NYM # 179; AM-05
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2003
• Est. completion date: June 2012

Study information

• Verified date: September 2020
• Source: New York Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Methodist Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Int J Radiat Oncol Biol Phys. 2003 Mar 15;55(4):1158. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year overall survival rate	Follow up for survival will be done to know this outcome	Up to June 2010
Secondary	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	year 2010
Secondary	Occurrence of pathological response or shrinkage of the tumor (becomes resectable)	Follow up for tumor response will be done to know this outcome	year 2010