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Colorectal CancerPhase 3NCT00064181

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

A Phase 3 study testing FOLFIRI regimen, capecitabine and celecoxib in people with Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
FOLFIRI regimen, capecitabine and celecoxib
How many people
86 participants
Where
28 sitesin 5 countries
Study dates
May 2003to Jan 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

28 sites in 5 countries.

28 sites in 5 countries

Germany18 sites

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • General Hospital

    Celle, 29223

  • Universitatsklinikum Carl Gustav Carl Carus

    Dresden, D-01307

  • Kliniken Essen - Mitte

    Essen, D-45136

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Klinikum der Albert - Ludwigs - Universitaet Freiburg

    Freiburg im Breisgau, D-79106

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Universitaets-Krankenhaus Eppendorf

    Hamburg, D-20246

  • St. Marien Hospital

    Hamm, 59065

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Vinzentiuskrankenhaus

    Landau, D-76829

  • Onkologische Schwerpunktpraxis Leer

    Leer, D-26789

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120

  • Kreiskrankenhaus Meissen

    Meissen, D-01662

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Eberhard Karls Universitaet

    Tübingen, D-72076

  • Universitaets-Hautklinik Wuerzburg

    Würzburg, D-97080

Other trials in Germany

Belgium6 sites

  • Ziekenhuis Network Antwerpen Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Cazk Groeninghe - Campus St-Niklaas

    Kortrijk, B-8500

  • St. Elizabeth Ziekenhuis

    Turnhout, 2300

Other trials in Belgium

Israel2 sites

  • Rambam Medical Center

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 58100

Other trials in Israel

Egypt1 site

  • National Cancer Institute - Cairo

    Cairo

Other trials in Egypt

Hungary1 site

  • National Institute of Oncology

    Budapest, 1122

Other trials in Hungary

About this study

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

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.

Read the 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.

Keywords
adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study startMay 2003
  3. Primary completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064181
Sponsor's protocol ID
EORTC-40015
Other IDs
EORTC-40015
Status last verified
Sep 2012
First submitted
8 Jul 2003
Last updated
24 Sep 2012
Results posted
No

Publications

  • 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.

    PubMed 18065406

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFIRI regimen, capecitabine and celecoxib in people with Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany, Belgium, Israel, Egypt, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064181, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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