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Phase II, Randomized, Double-Blind, Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-11/5fu/LV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis, Colorectal Neoplasms

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Trial Information

Phase II, Randomized, Double-Blind, Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-11/5fu/LV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer


Inclusion Criteria:



- Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with
evidence of metastatic disease and present or past histological documentation of
adenocarcinoma of the colon or rectum.

- Tumor must be measureable.

- Resolution of all acute toxic effects of any prior radiotherapy or surgical
procedure.

- ECOG performance status 0 or 1. Age >= 18 years.

- Required baseline laboratory.

- Negative pregnancy test.

- Willingness and ability to comply with the treatment plan.

Exclusion Criteria:

- Current enrollment in another clinical trial.

- Prior adjuvant therapy for colorectal cancer <= 6 months prior to randomization.

- Prior systemic anticancer therapy or intra-arterial cytotoxic chemotherapy given as
treatment for metastatic colorectal cancer.

- Known allergy to CPT-11, 5-FU, LV, celecoxib, other COX-2 inhibitors, non-steroidal
anti-inflammatory drugs (NSAIDS), salicylates, or sulfonamides.

- Chronic concomitant use of full-dose aspirin, other NSAIDs or other COX-2 inhibitors
for a chronic nonmalignant condition.

- A requirement for chronic concomitant use of low-dose (cardioprotective) aspirin.

- Chronic oral steroid use for treatment of a non-malignant condition.

- Known ulceration of the gastric or duodenal mucosa <= 30 days prior to randomization.

- Need for concomitant fluconazole or lithium.

- Any known significant bleeding disorder.

- Active inflammatory bowel disease or chronic diarrhea.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

IQ8-01-02-016

NCT ID:

NCT00037180

Start Date:

April 2002

Completion Date:

January 2003

Related Keywords:

  • Neoplasm Metastasis
  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteMilwaukee, Wisconsin  53215