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

Phase 2
18 Years
85 Years
Not Enrolling
Colorectal Neoplasms, Colonic Neoplasms

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Trial Information

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

Inclusion 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

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

December 2003

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Neoplasms
  • colon
  • rectum
  • colorectal
  • rectal
  • cancer
  • tumor
  • tumour
  • neoplasm
  • carcinoma
  • intravenous
  • epothilone
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms



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