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EPO906 Therapy in Patients with Advanced Colorectal Cancer



EPO906 Therapy in Patients with Advanced Colorectal Cancer

For Condition: Colonic Neoplasms,Colorectal Neoplasms
Status: Suspended
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause colorectal cancer.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must meet the following criteria to be eligible for the study: - Histologically or cytologically documented evidence of colorectal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation) - The patient should have failed or progressed on no more than two prior chemotherapies for metastatic disease (the prior chemotherapy must have included a fluoropyrimidine and either Irinotecan or oxaliplatin, or any combination of these agents, with the last chemotherapy having contained Irinotecan or oxaliplatin) - Patients who have received only adjuvant therapy for their disease are eligible, as long as they have relapsed within six months of completing such therapy and that therapy contained 5-FU and Irinotecan or oxaliplatin administered in combination as part of an investigational protocol - Must have a life expectancy of greater than three (3) months. Exclusion Criteria The following patients are not eligible for the study: - Patients with symptomatic CNS metastases or leptomeningeal involvement - Patients with unresolved bowel obstruction - Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 - Patients with severe cardiac insufficiency - Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry - Patients with radiation therapy or chemotherapy within the last four weeks - Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports - History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ - Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae - HIV+ patients - Pregnant or lactating females
Total Enrollment: 48

Location and Contact Information:

San Juan CCOP VA Medical Center
San Juan,  ,  00927
Puerto Rico
 

UCLA Medical Center
Los Angeles,  California,  90095
United States
 

Cancer Institute of New Jersey (CINJ)
New Brunswick,  New Jersey,  08901
United States
 

University of Pennsylvania Presbyterian Medical Center
Philadelphia,  Pennsylvania,  19104-4238
United States
 


Additional Information:
Study ID Numbers:
  CEPO906A-2201; 
Study Start Date: May 2002
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035087

Other Colorectal Neoplasms Studies:
1. Women's Health Initiative (WHI)

2. EPO906 Therapy in Patients with Advanced Colorectal Cancer

3. A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab

4. An Open Label Study of a Peptide Vaccine in Patients with Stage III Colon Cancer

5. First-line treatment of metastatic colorectal cancer with oxaliplatin/5-FU/leucovorin plus PTK787/ZK 222584 or placebo

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EPO906 Therapy in Patients with Advanced Colorectal Cancer

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