EPO906 Therapy in Patients With Advanced Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035087
• Other study ID #: CEPO906A2201
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: December 3, 2013
• Start date: May 2002
• Est. completion date: March 2003

Study information

• Verified date: December 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Neoplasms

Intervention

Drug:
• epothilone b

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey (CINJ)	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary	Time to progression
Secondary	Overall survival