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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 Site Birmingham, Alabama  35205
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Milwaukee, Wisconsin  53215