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BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
Study NCT00033306   Information provided by National Cancer Institute (NCI)
First Received: April 9, 2002   Last Updated: May 30, 2009   History of Changes

April 9, 2002
May 30, 2009
February 2002
 
 
 
Complete list of historical versions of study NCT00033306 on ClinicalTrials.gov Archive Site
 
 
 
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic colorectal cancer.

OBJECTIVES:

  • 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 CR.

Patients are followed every 3 months.

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

Phase II
Interventional
Treatment
Colorectal Cancer
Drug: ixabepilone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count greater than 125,000/mm^3

Hepatic:

  • 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)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • 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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent immunotherapy
  • No growth factors for 24 hours before and after cytotoxic chemotherapy

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

Radiotherapy:

  • 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

Surgery:

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

Other:

  • No other concurrent experimental anticancer medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033306
 
CDR0000069272, UAB-0145, BMS-CA163-012, UAB-F011029021, NCI-G02-2051
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: Andres Forero-Torres, MD, CSU University of Alabama at Birmingham
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP