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Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00230399
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : April 21, 2015
Information provided by:
University of Michigan Rogel Cancer Center

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 30, 2005
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE June 2003
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
To determine the objective response rate to the combination of celecoxib, capecitabine, and irinotecan in patients with metastatic colorectal cancer.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
To evaluate the time to progression of metastatic colorectal cancer after treatment with celecoxib, capecitabine, and irinotecan.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE C-2424: Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
Brief Summary This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Celecoxib
  • Drug: Capecitabine
  • Drug: Irinotecan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: March 13, 2007)
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE March 2008
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient must have a histologically proven adenocarcinoma of colon or rectum with metastases or local recurrence.
  2. Patients must have at least one measurable lesion according to the RECIST criteria. Bone metastases, ascites and pleural effusion are not measurable.
  3. Minimum indicator lesion size as follows:

    Greater than or equal to 20 mm measured by conventional CT Greater than or equal to 10 mm measured by spiral techniques

  4. Prior use of celecoxib for the treatment of nonmalignant disorders is allowed.
  5. Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
  6. Patients must have a calculated creatinine clearance of greater than 50 ml/min.
  7. Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
  8. Patients must have recovered from any effects of surgery.
  9. Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
  10. Patients must provide a signed consent to participate in the study.

Exclusion Criteria:

  1. Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
  2. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
  3. Patients who have received prior chemotherapy for colorectal cancer (including capecitabine or irinotecan) except for patients relapsing more than 6 months after completion of adjuvant chemotherapy.
  4. History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
  5. Unresolved bacterial infection requiring treatment with antibiotics.
  6. Pregnant or lactating women may not participate in the study. Women/men of reproductive age group may not participate unless they have agreed to use an effective method of contraception.
  7. Patients who have allergy to any of the study drugs or sulfa drugs.
  8. Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
  9. Gilbert's disease.
  10. Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow tablets or those who have malabsorption syndrome.
  11. Other serious concurrent infection
  12. Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
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 United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00230399
Other Study ID Numbers  ICMJE UMCC 3-24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Mark Zalupski, University of Michigan Comprehensive Cancer Center
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Zalupski, M.D. University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date April 2015

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