Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:6/30/2016
Start Date:January 2006
End Date:June 2010

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

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.

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.

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
We found this trial at
10
sites
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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106 Bow Street
Elkton MD, Maryland 21921
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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Lewes, DE
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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Voorhees, NJ
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101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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Chapel Hill, NC
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300 W 10th Ave
Columbus, Ohio 43210
(800) 293-5066
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center...
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Columbus, OH
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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Newark, DE
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San Diego, CA
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