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A Phase II, Randomized, Open-Label, Controlled, Dose-Elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer


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

Thank you

Trial Information

A Phase II, Randomized, Open-Label, Controlled, Dose-Elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer


Other specific inclusion/exclusion criteria may apply. In order to determine eligibility,
further examination by the investigator is necessary.

Inclusion Criteria:



- Age 18 years or older

- Diagnosis of colorectal cancer or adenocarcinoma of the appendix

- A tumor mass that can be measured

- Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC
grade less than or equal to 1

- Willingness and ability to comply with scheduled visits, treatment plan, and
laboratory tests, and other study procedures

Exclusion Criteria:

- Women that are pregnant or lactating

- Prior treatment with Irinotecan

- Partial or complete bowel obstruction, known chronic malabsorption, or total
colectomy or other major abdominal surgery that might result in substantial
alteration in transit or absorption of oral medication

- Administration of the last dose of any previous adjuvant therapy for colorectal
cancer within 6 months previous to randomization

- Current enrollment in another clinical trial

- Administration of any prior systemic anticancer therapy for metastatic colorectal
cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

440E-ONC-0020-315

NCT ID:

NCT00040391

Start Date:

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Diarrhea
  • Pharmacia
  • Neoplasms
  • Colorectal Neoplasms
  • Diarrhea

Name

Location

Research CenterBerkeley, California  94704
Research CenterWest Boylston, Massachusetts  01583
Research CenterAnn Arbor, Michigan  48109
Research CenterNashville, Tennessee  37232-6868
Research CenterArlington, Texas  76012
Research CenterCleveland, Ohio  44106
Research CenterMarshfield, Wisconsin  54449
Research CenterLittle Rock, Arkansas  72205
Research CenterJacksonville, Florida  32207
Research CenterNew Orleans, Louisiana  70115
Research CenterScarborough, Maine  04074-9308
Research CenterMinneapolis, Minnesota  55455
Research CenterSt. Joseph, Missouri  64507
Research CenterLas Vegas, Nevada  89106
Research CenterEast Setauket, New York  11733
Research CenterBurlington, North Carolina  27216
Research CenterLancaster, Pennsylvania  17605
Research CenterCharleston, South Carolina  29403