Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

NCT ID: NCT00311610

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SN-38 liposome

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.

Group Type: EXPERIMENTAL

SN-38 liposome

Intervention Type: DRUG

38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression

Interventions

SN-38 liposome

38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allyson Ocean, MD

Role: STUDY_CHAIR

Weill Medical College of Cornell University

Locations

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Kinston Medical Specialists

Kinston, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-80402

Identifier Type: -

Identifier Source: secondary_id

CDR0000467234

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-80402

Identifier Type: -

Identifier Source: org_study_id