A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Celgene Corporation
Study ID
NCT00040391
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Investigational drug — DRUG
  • Irinotecan — DRUG
  • 5-fluorouracil — DRUG
  • Leucovorin — DRUG

Study Details

The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.

Key Dates

Start date
Jun 30, 2002
Status verified
Nov 2016

Study Design

Primary purpose
TREATMENT

Locations (28)

FacilityCityStateZIPSite coordinators
Research CenterLittle RockArkansas72205-
Research CenterAnaheimCalifornia92801-
Research CenterConcordCalifornia94520-
Research CenterGilroyCalifornia95020-
Research CenterLos AngelesCalifornia90057-
Research CenterJacksonvilleFlorida32207-
Research CenterNew Port RicheyFlorida34652-
Research CenterNew OrleansLouisiana70115-
Research CenterScarboroughMaine04074-9308-
Research CenterPittsfieldMassachusetts01201-
Research CenterEast LansingMichigan48824-
Research CenterSaint JosephMichigan49085-
Research CenterMinneapolisMinnesota55455-
Research CenterSaint JosephMissouri64507-
Research CenterLas VegasNevada89106-
Research CenterEast SetauketNew York11733-
Research CenterNorthportNew York11768-2364-
Research CenterBurlingtonNorth Carolina27216-
Research CenterGreenvilleNorth Carolina27834-
Research CenterZanesvilleOhio43701-
Research CenterLancasterPennsylvania17605-
Research CenterPhiladelphiaPennsylvania19140-5189-
Research CenterCharlestonSouth Carolina29403-
Research CenterCharlestonSouth Carolina29406-
Research CenterGermantownTennessee38138-
Research CenterDallasTexas75230-
Research CenterMadisonWisconsin53792-2454-
Research CenterMilwaukeeWisconsin53215-

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