Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically determined metastatic colorectal cancer* Primary lesion confirmed endoscopically, surgically, or radiologically NOTE: * Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease, unless more than 5 years between primary surgery and development of metastatic disease OR primary cancer was stage I Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Nonmeasurable lesions include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions UGT1A1*1 homozygous or UGT1A1*28 heterozygous genotype status Patients with homozygous UGT1A1*28 genotype not eligible Received at least 1 prior regimen with oxaliplatin for metastatic disease Recurrent disease following prior adjuvant therapy allowed PATIENT CHARACTERISTICS: ECOG performance status 0-1 Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Creatinine normal Bilirubin normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception duration and for 3 months after completion of study treatment No known Gilbert's disease or other chronic liver disease No colonic or small bowel disorders (e.g., inflammatory bowel disease, Crohn's disease, or ulcerative colitis) that predispose the patients to uncontrolled diarrhea (i.e., > 3 watery or soft stools daily at baseline in patients without a colostomy or ileostomy) PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy No prior irinotecan Prior pelvic radiotherapy allowed as long as measurable lesion is outside irradiated field No concurrent palliative radiotherapy No other concurrent chemotherapy No concurrent steroids except those given for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic or for prevention of infusion reaction
Sites / Locations
- Kaiser Permanente Medical Office -Vandever Medical Office
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Union Hospital Cancer Program at Union Hospital
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Cancer Institute of New Jersey at Cooper - Voorhees
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Kinston Medical Specialists
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
SN-38 liposome
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 3 years.