Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer

NCT00003426 | Completed Phase 1

• 3 other identifiers: 98-019CDR0000066451NCI-H98-0020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that can not be surgically removed.

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Interventions

gemcitabine hydrochloride DRUG

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced and/or unresectable adenocarcinoma of the pancreas No metastatic disease No completely resected pancreatic cancer PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% OR ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No congestive heart failure No New York Heart Association class III and IV heart disease Other: Not pregnant No concurrent medical problems that would increase the side effects or morbidity of chemoradiation No concurrent medical condition that would make patient ineligible to receive external beam radiation such as: Crohn's disease Inflammatory bowel disease No active infection requiring systemic antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior gemcitabine No prior chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pancreas Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• David Paul Kelsen, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: December 2, 2003
• Study Start: April 1, 1998
• Primary Completion: March 1, 2002
• Study Completion: March 1, 2002
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

US (1)