EPO906 Therapy in Patients With Advanced Colorectal Cancer

NCT00035087 | Completed Phase 2

• 1 other identifier: CEPO906A2201
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Keywords

colon; rectum; colorectal; rectal; cancer; tumor; tumour; neoplasm; carcinoma; intravenous; epothilone

Outcome Measures

Primary Outcomes (1)

• Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcomes (2)

• Time to progression

• Overall survival

Interventions

epothilone b DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Neoplasms; Carcinoma

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: May 1, 2002
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

US (1)