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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00311610 |
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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: SN-38 liposome |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin |
Estimated Enrollment: | 54 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically determined metastatic colorectal cancer*
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:
UGT1A1*1 homozygous or UGT1A1*28 heterozygous genotype status
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Kaiser Permanente Medical Office -Vandever Medical Office | |
San Diego, California, United States, 92120 | |
United States, Delaware | |
CCOP - Christiana Care Health Services | |
Newark, Delaware, United States, 19713 | |
Tunnell Cancer Center at Beebe Medical Center | |
Lewes, Delaware, United States, 19958 | |
United States, Maryland | |
Union Hospital Cancer Program at Union Hospital | |
Elkton MD, Maryland, United States, 21921 | |
United States, Nevada | |
CCOP - Nevada Cancer Research Foundation | |
Las Vegas, Nevada, United States, 89106 | |
University Medical Center of Southern Nevada | |
Las Vegas, Nevada, United States, 89102 | |
United States, New Jersey | |
Cancer Institute of New Jersey at Cooper - Voorhees | |
Voorhees, New Jersey, United States, 08043 | |
United States, North Carolina | |
Kinston Medical Specialists | |
Kinston, North Carolina, United States, 28501 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210-1240 |
Investigator: | Allyson J. Ocean, MD | Weill Medical College of Cornell University |
Study Chair: | Allyson J. Ocean, MD | Weill Medical College of Cornell University |
Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
Study ID Numbers: | CDR0000467234, CALGB-80402 |
Study First Received: | April 5, 2006 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00311610 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Rectal Neoplasm Disease Progression Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Oxaliplatin Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |