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Spots Global Cancer Trial Database for DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas

Official Title: A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas

Study ID: NCT00003951

Interventions

exatecan mesylate

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy.

Detailed Description: OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma of the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression in patients receiving this drug. III. Determine the survival at 6 and 12 months of patients receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this regimen in this patient population. V. Evaluate the pharmacokinetics of this drug in this patient population. OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Johns Hopkins Oncology Center, Baltimore, Maryland, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Contact Details

Name: Robert L. DeJager, MD, FACP

Affiliation: Daiichi Sankyo

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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