Status:
COMPLETED
Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This ...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer. Secondary * Determine ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00311610
Start Date
January 1 2006
End Date
June 1 2010
Last Update
June 29 2016
Active Locations (10)
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1
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92120
2
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
3
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
4
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921