Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Irinotecan and Celecoxib in Treating Patients With Unresectable or Metastatic Colorectal Cancer

Lead Sponsor:

Roswell Park Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer

Diarrhea

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 blockin...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of irinotecan when administered with celecoxib in patients with unresectable or metastatic colorectal cancer. Secondary * Determine the d...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 3,000/mm\^3
  • Hepatic
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal
  • No Gilbert's disease
  • Renal
  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min
  • Cardiovascular
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Gastrointestinal
  • Able to receive oral medications
  • No prior inflammatory bowel disease
  • No active ulcer disease or gastritis
  • No contraindications for sigmoidoscopy
  • No active colostomy
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Chemotherapy
  • 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
  • Radiotherapy
  • 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
  • Surgery
  • No prior abdominoperineal resection
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    2 Patients enrolled

    Trial Details

    Trial ID

    NCT00084721

    Start Date

    March 1 2005

    Last Update

    January 31 2013

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Roswell Park Cancer Institute

    Buffalo, New York, United States, 14263-0001