Clinical trial NCT00226746: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Carcinoma, Pancreatic Ductal
Keywords: Pancreatic Cancer
Hyperfractionated Radiation Therapy
Gemcitabine
Paclitaxel
Carcinoma, Pancreatic Ductal
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: One-year overall survival rate
timeFrame: Up to June 2010
Secondary outcomes:
measure: Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
timeFrame: year 2010
measure: Occurrence of pathological response or shrinkage of the tumor (becomes resectable)
timeFrame: year 2010
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Hani Ashamalla, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
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.