For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Neoplasm Metastasis

Colorectal Neoplasms

Treatments

Drug: Irinotecan

Drug: Celecoxib

Drug: 5-fluorouracil

Drug: Leucovorin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00037180

IQ8-01-02-016

Details and patient eligibility

About

The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.