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EPO906 Therapy in Patients With Advanced Colorectal Cancer
This study has been completed.
First Received: May 2, 2002   Last Updated: November 18, 2009   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00035087
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Colonic Neoplasms
Drug: epothilone b
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Enrollment: 62
Study Start Date: May 2002
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035087

Locations
United States, New Jersey
Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CEPO906A2201
Study First Received: May 2, 2002
Last Updated: November 18, 2009
ClinicalTrials.gov Identifier: NCT00035087     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
colon
rectum
colorectal
rectal
cancer
tumor
tumour
neoplasm
carcinoma
intravenous
epothilone

Additional relevant MeSH terms:
Epothilone B
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Epothilones
Mitosis Modulators
Colonic Diseases
Antimitotic Agents
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Tubulin Modulators
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009