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

NCT00226746 | Withdrawn Phase 2 DMC

• 1 other identifier: NYM # 179; AM-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

Pancreatic Cancer; Hyperfractionated Radiation Therapy; Gemcitabine; Paclitaxel; Carcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (1)

• One-year overall survival rate

  Follow up for survival will be done to know this outcome

  Up to June 2010

Secondary Outcomes (2)

• Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary

  year 2010

• Occurrence of pathological response or shrinkage of the tumor (becomes resectable)

  year 2010

Study Arms (1)

Paclitaxel and Gemcitabine

EXPERIMENTAL

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

Interventions

Paclitaxel and gemcitabine 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.

Paclitaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related 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. doi: 10.1016/s0360-3016(02)03791-4.

  PMID: 12573755 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms

Interventions

Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hani Ashamalla, MD, FCCP

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: March 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2012
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

US (1)