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

NCT00064181 | Completed Phase 3

• 1 other identifier: EORTC-40015
• Study Type: interventional
• Target: 86
• Locations: 5 countries
• Sites: 28

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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV colon cancer; stage IV rectal cancer

Interventions

FOLFIRI regimen DRUG

capecitabine DRUG

celecoxib DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic disease * Measurable disease * Patients who received prior radiotherapy must have measurable or evaluable disease outside the radiotherapy field * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases) Renal * Creatinine clearance at least 51 mL/min * No severe renal impairment Cardiovascular * No severe cardiac disease * No uncontrolled angina pectoris * No myocardial infarction within the past 6 months Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study participation * No active Crohn's disease * No other malignancy except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No other uncontrolled severe medical condition * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent active or passive immunotherapy for colon cancer Chemotherapy * No prior chemotherapy for metastatic disease Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * At least 6 months since prior adjuvant therapy * More than 4 weeks since prior investigational drugs * No concurrent sorivudine or chemically related analogues (e.g., brivudine) * No other concurrent investigational drugs * No other concurrent cytotoxic agents * No concurrent prophylactic fluconazole * No concurrent or planned cyclo-oxygenase-2 (COX-2) inhibitors or nonsteroidal anti-inflammatory drugs * No concurrent chronic use of full-dose aspirin (325 mg/day or greater) * Concurrent low-dose (cardioprotective) aspirin prophylaxis (no more than 325 mg every other day OR no more than 162.5 mg per day) allowed

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (28)

Ziekenhuis Network Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Cazk Groeninghe - Campus St-Niklaas

Kortrijk, B-8500, Belgium

Location

St. Elizabeth Ziekenhuis

Turnhout, 2300, Belgium

Location

National Cancer Institute - Cairo

Cairo, Egypt

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

General Hospital

Celle, 29223, Germany

Location

Universitatsklinikum Carl Gustav Carl Carus

Dresden, D-01307, Germany

Location

Kliniken Essen - Mitte

Essen, D-45136, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Klinikum der Albert - Ludwigs - Universitaet Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

Location

Allgemeines Krankenhaus Altona

Hamburg, 22763, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

St. Marien Hospital

Hamm, 59065, Germany

Location

Westpfalz-Klinikum GmbH

Kaiserslautern, D-67653, Germany

Location

Vinzentiuskrankenhaus

Landau, D-76829, Germany

Location

Onkologische Schwerpunktpraxis Leer

Leer, D-26789, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Kreiskrankenhaus Meissen

Meissen, D-01662, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

Universitaets-Hautklinik Wuerzburg

Würzburg, D-97080, Germany

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Related Publications (3)

• Kohne CH, De Greve J, Hartmann JT, Lang I, Vergauwe P, Becker K, Braumann D, Joosens E, Muller L, Janssens J, Bokemeyer C, Reimer P, Link H, Spath-Schwalbe E, Wilke HJ, Bleiberg H, Van Den Brande J, Debois M, Bethe U, Van Cutsem E. Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. Ann Oncol. 2008 May;19(5):920-6. doi: 10.1093/annonc/mdm544. Epub 2007 Dec 6.

  PMID: 18065406 RESULT

• De Grève J, Koehne C, Hartmann J, et al.: Capecitabine plus irinotecan versus 5-FU/FA/irinotecan ± celecoxib in first line treatment of metastatic colorectal cancer (CRC). Long-term results of the prospective multicenter EORTC phase III study 40015. [Abstract] J Clin Oncol 24 (Suppl 18): A-3577, 2006.

  RESULT

• Kohne C, De Greve J, Bokemeyer C, et al.: Capecitabine plus irinotecan versus 5-FU/FA/irinotecan +/- celecoxib in first line treatment of metastatic colorectal cancer. Safety results of the prospective multicenter EORTC phase III study 40015. [Abstract] J Clin Oncol 23 (Suppl 16): A-3525, 252s, 2005.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Celecoxib; Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Claus-Henning Koehne, MD

  Klinikum Oldenburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: May 1, 2003
• Primary Completion: January 1, 2005
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

DE (18); BE (6); HU (1); EG (1); IL (2)