⭐️⭐️⭐️⭐️⭐️ "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 Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal 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: Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer

Official Title: Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer

Study ID: NCT00064181

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy such as irinotecan, capecitabine, leucovorin, and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known which combination chemotherapy regimen with or without celecoxib is more effective in treating metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens and celecoxib to see how well they work compared to two combination chemotherapy regimens alone in treating patients with metastatic colorectal cancer.

Detailed Description: OBJECTIVES: * Compare the progression-free survival of patients with metastatic colorectal cancer treated with capecitabine and irinotecan vs fluorouracil, leucovorin calcium, and irinotecan with vs without celecoxib. * Compare the safety of these regimens in these patients. * Compare the response rate in patients treated with these regimens. * Compare the time to treatment failure and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, double-blind\*, multicenter study. Patients are stratified according to participating center, prior adjuvant therapy (yes vs no), and risk group (poor vs intermediate vs good). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive irinotecan IV over 30-90 minutes on days 1 and 22; oral capecitabine twice daily on days 1-15 and 22-36; and oral celecoxib twice daily on days 1-42. * Arm II: Patients receive irinotecan and capecitabine as in arm I and oral placebo twice daily on days 1-42. * Arm III: Patients receive irinotecan IV over 30-90 minutes on days 1, 15, and 29; leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on days 1, 2, 15, 16, 29, and 30; and oral celecoxib twice daily on days 1-42. * Arm IV: Patients receive irinotecan, CF, and 5-FU as in arm III and oral placebo twice daily on days 1-42. In all arms, treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. If all chemotherapy is discontinued due to toxicity, patients may continue celecoxib or placebo until disease progression, unacceptable toxicity, or starting a new cytotoxic regimen. NOTE: \*The double-blind treatment only applies to the celecoxib and placebo randomization Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 692 patients (173 per treatment arm) will be accrued for this study within 3.5 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ziekenhuis Network Antwerpen Middelheim, Antwerp, , Belgium

Institut Jules Bordet, Brussels, , Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

Cazk Groeninghe - Campus St-Niklaas, Kortrijk, , Belgium

St. Elizabeth Ziekenhuis, Turnhout, , Belgium

National Cancer Institute - Cairo, Cairo, , Egypt

Charite - Campus Charite Mitte, Berlin, , Germany

General Hospital, Celle, , Germany

Universitatsklinikum Carl Gustav Carl Carus, Dresden, , Germany

Kliniken Essen - Mitte, Essen, , Germany

Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany

Klinikum der Albert - Ludwigs - Universitaet Freiburg, Freiburg, , Germany

Allgemeines Krankenhaus Hagen, Hagen, , Germany

Allgemeines Krankenhaus Altona, Hamburg, , Germany

Universitaets-Krankenhaus Eppendorf, Hamburg, , Germany

St. Marien Hospital, Hamm, , Germany

Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany

Vinzentiuskrankenhaus, Landau, , Germany

Onkologische Schwerpunktpraxis Leer, Leer, , Germany

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg, Magdeburg, , Germany

Kreiskrankenhaus Meissen, Meissen, , Germany

Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, , Germany

Eberhard Karls Universitaet, Tuebingen, , Germany

Universitaets-Hautklinik Wuerzburg, Wuerzburg, , Germany

National Institute of Oncology, Budapest, , Hungary

Rambam Medical Center, Haifa, , Israel

Wolfson Medical Center, Holon, , Israel

Contact Details

Name: Claus-Henning Koehne, MD

Affiliation: Klinikum Oldenburg

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: