Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311610
• Other study ID #: CALGB-80402
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2006
• Last updated: June 28, 2016
• Start date: January 2006
• Est. completion date: June 2010

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• SN-38 liposome
38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Union Hospital Cancer Program at Union Hospital	Elkton MD	Maryland
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		q 2 cycles during tx	No
Secondary	Toxicity		q cycle during tx	Yes
Secondary	Progression-free survival		3 years	No
Secondary	Overall survival		3 years	No