BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00033306
• Other study ID #: CDR0000069272
• Secondary ID: UAB-0145BMS-CA16
• Status: Terminated
• Phase: Phase 2
• First received: April 9, 2002
• Last updated: August 1, 2013
• Start date: February 2002
• Est. completion date: July 2005

Study information

• Verified date: August 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• ixabepilone

• Fluoropyrimidine

• Irinotecan

Locations

Country	Name	City	State
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline to survival	No
Secondary	Determine the safety of this drug in these patients.		baseline to survival	Yes
Secondary	Determine the response duration, time to progression, and survival in patients treated with this drug.		baseline to survival	Yes