Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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 phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer.

Detailed Description
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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 the toxicity profile of this drug in these patients. Determine the proportion of patients treated with this drug who experience any grade 3 or greater toxicity. Determine progression-free survival and overall survival for patients treated with this drug. OUTLINE: This is a multicenter study. 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.

Official Title
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Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: SN-38 liposome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SN-38 liposome<br>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. | Drug: SN-38 liposome<br>* 38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | q 2 cycles during tx | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | q cycle during tx | 
| Progression-free survival |  | 3 years | 
| Overall survival |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer