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Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SN-38 liposome
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

SN-38 liposome

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Toxicity
Progression-free survival
Overall survival

Full Information

First Posted
April 5, 2006
Last Updated
June 28, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00311610
Brief Title
Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
Official Title
Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SN-38 liposome
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SN-38 liposome
Intervention Description
38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
q 2 cycles during tx
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
q cycle during tx
Title
Progression-free survival
Time Frame
3 years
Title
Overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allyson Ocean, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Permanente Medical Office -Vandever Medical Office
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Union Hospital Cancer Program at Union Hospital
City
Elkton MD
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

Learn more about this trial

Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

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