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EPO906 Therapy in Patients With Advanced Colorectal Cancer

Primary Purpose

Colorectal Neoplasms, Colonic Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epothilone b
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colon, rectum, colorectal, rectal, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey (CINJ)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to progression
Overall survival

Full Information

First Posted
May 2, 2002
Last Updated
December 3, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00035087
Brief Title
EPO906 Therapy in Patients With Advanced Colorectal Cancer
Official Title
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colonic Neoplasms
Keywords
colon, rectum, colorectal, rectal, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epothilone b
Primary Outcome Measure Information:
Title
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary Outcome Measure Information:
Title
Time to progression
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Institute of New Jersey (CINJ)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

EPO906 Therapy in Patients With Advanced Colorectal Cancer

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