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Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2009
First Received: April 5, 2006   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00311610
  Purpose

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

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response (complete or partial response) as measured by RECIST [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability (early diarrhea, late diarrhea, or febrile neutropenia ≥ grade 3) [ Designated as safety issue: Yes ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: February 2006
Estimated Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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 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.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311610

Locations
United States, California
Kaiser Permanente Medical Office -Vandever Medical Office Recruiting
San Diego, California, United States, 92120
Contact: Han A. Koh     619-528-2596        
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services     302-733-6227        
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center     302-645-3171        
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
United States, Maryland
Union Hospital Cancer Program at Union Hospital Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD     302-366-1200        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM     702-384-0013        
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM     702-384-0013        
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
United States, North Carolina
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD     252-559-2200ext.201        
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente     877-668-0683; 919-966-4432        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Investigator: Allyson J. Ocean, MD Weill Medical College of Cornell University
Study Chair: Allyson J. Ocean, MD Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
Ocean AJ, Niedzwiecki D, Atkins JN, et al.: LE-SN38 for metastatic colorectal cancer after progression on oxaliplatin: results of CALGB 80402. [Abstract] J Clin Oncol 26 (Suppl 15): A-4109, 2008.

Responsible Party: Cancer and Leukemia Group B ( Richard L. Schilsky )
Study ID Numbers: CDR0000467234, CALGB-80402
Study First Received: April 5, 2006
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00311610     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009