Clinical trial NCT00033306: BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
Official title: A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: baseline to survival
Secondary outcomes:
measure: Determine the safety of this drug in these patients.
timeFrame: baseline to survival
measure: Determine the response duration, time to progression, and survival in patients treated with this drug.
timeFrame: baseline to survival
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
Study officials:
affiliation: University of Alabama at Birmingham
name: Andres Forero-Torres, MD, CSU
role: STUDY_CHAIR
References: