BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Cancer Institute (NCI)
• Treatments: Irinotecan

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