Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00064181
First received: July 8, 2003
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFIRI regimen Drug: capecitabine Drug: celecoxib Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
Capecitabine
Celecoxib
U.S. FDA Resources
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
| Enrollment: | 86 |
| Study Start Date: | May 2003 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064181
Locations
| Belgium | |
| Ziekenhuis Network Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Cazk Groeninghe - Campus St-Niklaas | |
| Kortrijk, Belgium, B-8500 | |
| St. Elizabeth Ziekenhuis | |
| Turnhout, Belgium, 2300 | |
| Egypt | |
| National Cancer Institute - Cairo | |
| Cairo, Egypt | |
| Germany | |
| Charite - Campus Charite Mitte | |
| Berlin, Germany, D-10117 | |
| General Hospital | |
| Celle, Germany, 29223 | |
| Universitatsklinikum Carl Gustav Carl Carus | |
| Dresden, Germany, D-01307 | |
| Kliniken Essen - Mitte | |
| Essen, Germany, D-45136 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Klinikum der Albert - Ludwigs - Universitaet Freiburg | |
| Freiburg, Germany, D-79106 | |
| Allgemeines Krankenhaus Hagen | |
| Hagen, Germany, D-58095 | |
| Allgemeines Krankenhaus Altona | |
| Hamburg, Germany, 22763 | |
| Universitaets-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| St. Marien Hospital | |
| Hamm, Germany, 59065 | |
| Westpfalz-Klinikum GmbH | |
| Kaiserslautern, Germany, D-67653 | |
| Vinzentiuskrankenhaus | |
| Landau, Germany, D-76829 | |
| Onkologische Schwerpunktpraxis Leer | |
| Leer, Germany, D-26789 | |
| Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | |
| Magdeburg, Germany, D-39120 | |
| Kreiskrankenhaus Meissen | |
| Meissen, Germany, D-01662 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Eberhard Karls Universitaet | |
| Tuebingen, Germany, D-72076 | |
| Universitaets-Hautklinik Wuerzburg | |
| Wuerzburg, Germany, D-97080 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1122 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Claus-Henning Koehne, MD | Klinikum Oldenburg |
More Information
Additional Information:
Publications:
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.
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.
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00064181 History of Changes |
| Other Study ID Numbers: | EORTC-40015, EORTC-40015 |
| Study First Received: | July 8, 2003 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
adenocarcinoma of the colon adenocarcinoma of the rectum stage IV colon cancer stage IV rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Capecitabine Irinotecan Camptothecin |
Leucovorin Levoleucovorin Celecoxib Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on May 19, 2013