BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

NCT00033306 | Terminated Phase 2 DMC

• 5 other identifiers: CDR0000069272UAB-0145BMS-CA163-012UAB-F011029021NCI-G02-2051
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Determine the safety of this drug in these patients.

  baseline to survival

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

  baseline to survival

Study Arms (1)

BMS-247550

EXPERIMENTAL

Drug: ixabepilone; Drug: Fluoropyrimidine; Drug: Irinotecan

Interventions

ixabepilone DRUG

BMS-247550

Fluoropyrimidine DRUG

BMS-247550

Irinotecan DRUG

BMS-247550

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

ixabepilone; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Andres Forero-Torres, MD, CSU

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: August 6, 2003
• Study Start: February 1, 2002
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

US (2)