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

NCT ID: NCT00226746

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Carcinoma, Pancreatic Ductal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paclitaxel and gemcitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hani Ashamalla, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hani Ashamalla, MD, FCCP

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Brooklyn Methodist Hospital

Locations

New York Methodist Hospital

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12573755 (View on PubMed)

Other Identifiers

NYM # 179; AM-05

Identifier Type: -

Identifier Source: org_study_id