⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer

Official Title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer

Study ID: NCT00005053

Interventions

glufosfamide

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery.

Detailed Description: OBJECTIVES: I. Determine the activity of glufosfamide as determined by objective response in patients with metastatic or inoperable locally advanced pancreatic cancer. II. Determine the response rate in this patient population after this treatment. III. Determine the duration of objective response in these patients on this treatment. IV. Determine the toxic effects of this regimen in these patients. V. Assess the impact of hydration on the toxicity profile of this treatment in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms: Arm I: Patients receive glufosfamide IV over 1 hour on day 1. Arm II: Patients receive glufosfamide as in arm I. Patients are hydrated with excess physiological saline solution 4 hours before and for 3 hours after treatment with glufosfamide. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with an objective complete response continue treatment for a maximum of 2 courses beyond confirmation of response. Patients are followed every 6 weeks until disease progression. PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Herlev Hospital - University Hospital of Copenhagen, Herlev, , Denmark

Centre Leon Berard, Lyon, , France

CHU de la Timone, Marseille, , France

Centre Eugene Marquis, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Universitats-Krankenhaus Eppendorf, Hamburg, , Germany

Medizinische Hochschule Hannover, Hannover, , Germany

Haemato-Onkologische Praxis und Tagesklinik, Munich, , Germany

Klinikum Nurnberg, Nuremberg, , Germany

University of Ioannina, Ioannina, , Greece

Rambam Medical Center, Haifa, , Israel

Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands

Inselspital, Bern, Bern, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland

Contact Details

Name: Nicholas A. Pavlidis, MD

Affiliation: University of Ioannina

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: