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Trial record 65 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00064181
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE July 8, 2003
First Posted Date  ICMJE July 9, 2003
Last Update Posted Date September 24, 2012
Study Start Date  ICMJE May 2003
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00064181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
Official Title  ICMJE Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: FOLFIRI regimen
  • Drug: capecitabine
  • Drug: celecoxib
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September¬†20,¬†2012)
86
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Egypt,   Germany,   Hungary,   Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00064181
Other Study ID Numbers  ICMJE EORTC-40015
EORTC-40015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Claus-Henning Koehne, MD Klinikum Oldenburg
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP