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A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan


- Determine the clinical activity of BMS-247550, as measured by the tumor response rate,
in patients with metastatic colorectal cancer previously treated with a
fluoropyrimidine and irinotecan.

- Determine the safety of this drug in these patients.

- Determine the response duration, time to progression, and survival in patients treated
with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment repeats every 21 days for
up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete response (CR) receive up to 4 additional courses of treatment beyond

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for this study within 6 months.

Inclusion Criteria


- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma

- Prior treatment for metastatic disease with at least:

- One regimen of irinotecan in combination with a fluoropyrimidine OR

- Two regimens comprising fluoropyrimidine-based first-line therapy and
irinotecan-based second-line therapy

- May have received cetuximab and/or a fluoropyrimidine as part of second-
line therapy

- Disease progression during or within 4 months of treatment with irinotecan

- At least 1 bidimensionally measurable lesion

- No known CNS metastases



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count greater than 125,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present)


- Creatinine no greater than 1.5 times ULN


- No New York Heart Association class III or IV heart disease

- No history of unstable angina, myocardial infarction, or congestive heart failure
within the past 6 months


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known prior severe hypersensitivity reactions to agents containing Cremophor EL

- No motor or sensory neuropathy grade 2 or greater

- No concurrent serious uncontrolled infection or other nonmalignant medical illness

- No concurrent psychiatric disorders or other conditions that would preclude study

- No other active malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix


Biologic therapy:

- See Disease Characteristics

- No concurrent immunotherapy

- No growth factors for 24 hours before and after cytotoxic chemotherapy


- See Disease Characteristics

- Additional prior adjuvant or neoadjuvant chemotherapy allowed

- At least 4 weeks since prior chemotherapy and recovered

- No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease

- No prior oxaliplatin

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except hormone replacement therapy


- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to target lesion unless the lesion has shown progression after
completion of radiotherapy

- No concurrent therapeutic radiotherapy

- Focal radiotherapy for palliation of bone symptoms may be allowed


- At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered


- No other concurrent experimental anticancer medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Andres Forero-Torres, MD, CSU

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:




Start Date:

February 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Georgia Cancer Specialists Decatur, Georgia  30033