Irinotecan and Celecoxib in Treating Patients With Unresectable or 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. Identifier: NCT00084721
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : January 31, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving irinotecan with celecoxib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given with celecoxib in treating patients with unresectable or metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Diarrhea Drug: celecoxib Drug: irinotecan hydrochloride Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of irinotecan when administered with celecoxib in patients with unresectable or metastatic colorectal cancer.


  • Determine the dose-limiting toxic effects and non-dose-limiting toxic effects of this regimen in these patients.
  • Determine the incidence and intensity of diarrhea and myelotoxicity in patients treated with this regimen.
  • Determine any responses in patients treated with this regimen.
  • Determine potential mechanisms for irinotecan-induced diarrhea and protective effects of celecoxib on diarrhea prevention in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of irinotecan. Patients are assigned to 1 of 2 treatment groups.

  • Group I: Patients receive a fixed dose of irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral celecoxib twice daily on days 10-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
  • Group II: Patients receive irinotecan as in group I at escalating doses and oral celecoxib twice daily on days 0-42. Treatment continues as in group I.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 18-30 patients (9 for group I, 9-21 for group II) will be accrued for this study within 1-2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Primary Purpose: Treatment
Official Title: A Phase I Study of Irinotecan in Combination With Fixed Dose Celecoxib in Patients With Advanced Colorectal Cancer
Study Start Date : March 2005
Actual Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal cancer

    • Metastatic or unresectable disease
  • Failed first-line or second-line therapy OR recurred after receiving fluorouracil-based adjuvant chemotherapy
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3


  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal
  • No Gilbert's disease


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Able to receive oral medications
  • No prior inflammatory bowel disease
  • No active ulcer disease or gastritis
  • No contraindications for sigmoidoscopy
  • No active colostomy


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No prior allergic reaction to compounds of similar chemical or biological composition to irinotecan, celecoxib, sulfonamides, or other study agents
  • No active or ongoing infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)


  • See Disease Characteristics
  • No more than 2 prior different chemotherapy regimens, including adjuvant therapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior irinotecan

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy of more than 3,000 cGy
  • No prior radiotherapy to extended marrow-generating fields
  • No prior abdomino-pelvic irradiation


  • No prior abdominoperineal resection


  • More than 2 weeks since prior cyclo-oxygenase-2 (COX-2) inhibitors
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other anticancer therapy
  • No other concurrent COX-2 inhibitors

    • Low-dose aspirin allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00084721

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00084721     History of Changes
Other Study ID Numbers: RP 02-24
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Roswell Park Cancer Institute:
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
stage III colon cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents