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COMPLETEDPHASE2

Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

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

NCT00311610•Alliance for Clinical Trials in Oncology

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.

Eligibility

Age

18 - 120 years

Sex

ALL

Healthy Volunteers

Inclusion 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
+3 more criteria

Exclusion 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
+11 more criteria

Locations (10)

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

Key Dates

Start Date

January 1, 2006

Primary Completion Date

January 1, 2007

Completion Date

June 1, 2010

Last Updated

June 29, 2016

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

SN-38 liposome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease