A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Diarrhea |
Drug: Investigational drug Drug: Irinotecan Drug: 5-fluorouracil Drug: Leucovorin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 28 Study Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00040391 History of Changes |
| Other Study ID Numbers: | 440E-ONC-0020-315 |
| Study First Received: | June 26, 2002 |
| Last Updated: | March 13, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
Pharmacia |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Diarrhea Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive Signs and Symptoms Fluorouracil |
Irinotecan Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on June 18, 2013