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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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



- Determine the objective response rate following treatment with SN-38 liposome as a
second-line treatment in patients with metastatic colorectal cancer.


- 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

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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- Recovered from prior therapy

- No prior irinotecan

- Prior pelvic radiotherapy allowed as long as measurable lesion is outside irradiated

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

q 2 cycles during tx

Safety Issue:


Principal Investigator

Allyson J. Ocean, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

June 2010

Related Keywords:

  • Colorectal Cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms



CCOP - Christiana Care Health Services Wilmington, Delaware  19899
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Kaiser Permanente Medical Office -Vandever Medical Office San Diego, California  92120
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Kinston Medical Specialists Kinston, North Carolina  28501