Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer

May 20, 2014 updated by: University of Southern California

Phase II Randomized Placebo-Controlled Double-Blinded Study With 5-FU vs. 5-FU With IM862 With Cross-Over to CPT-11 vs. CPT-11 With IM862

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known if chemotherapy is more effective with or without IM-862 in treating colorectal cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer.

Study Overview

Status

Terminated

Conditions

Colorectal Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the efficacy of fluorouracil with or without IM-862 in terms of progression free survival in patients with previously untreated or recurrent metastatic adenocarcinoma of the colon or rectum. II. Determine the toxicity of IM-862 and fluorouracil in these patients. III. Determine the efficacy of IM-862 in combination with irinotecan in terms of progression free survival in patients who have disease progression after receiving fluorouracil. IV. Obtain preliminary data on molecular markers of response and time to progression by determining levels of genes involved in adhesion, angiogenesis, apoptosis, and drug resistance prior to and during chemotherapy. V. Determine the molecular correlates for response and time to progression through analysis of serum and urine markers of angiogenesis, such as vascular endothelial growth factor and fibroblast growth factor, in patients treated with IM-862 in combination with fluorouracil or irinotecan. VI. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients are randomized to one of two treatment arms: Arm I: Patients receive fluorouracil IV continuously on days 1-21 and IM-862 intranasally three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression. Patients who develop disease progression are taken off fluorouracil and IM-862, and then receive irinotecan IV over 90 minutes weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression. Arm II: Patients receive fluorouracil as in arm I and placebo intranasally three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression. Patients who develop disease progression are taken off fluorouracil and placebo, and then receive irinotecan and IM-862 as in arm I on days 1-42. Courses repeat every 6 weeks in the absence of disease progression. Quality of life is assessed prior to study, and then prior to every course during study. Patients are followed for a minimum of 6 months.

PROJECTED ACCRUAL: A total of 66 patients (33 per arm) will be accrued for this study within 26-27 months.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the colon or rectum Previously untreated OR Recurrent with a disease free period of at least 1 year Measurable or evaluable disease Tumor must be accessible for biopsy No brain metastasis

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastasis present) AST or ALT no greater than 2 times ULN (no greater than 5 times ULN if liver metastasis present) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No myocardial infarction within the past year No congestive heart failure Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No medical, social, or psychological factor that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior adjuvant immunotherapy with monoclonal antibody 17-1A allowed No prior IM-862 Chemotherapy: At least 1 year since prior chemotherapy for patients with recurrent metastatic adenocarcinoma of the colon or rectum Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (ACTUAL)

November 1, 2001

Study Completion (ACTUAL)

November 1, 2001

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

February 25, 2004

First Posted (ESTIMATE)

February 26, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000068052 (3C-99-3)
LAC-USC-3C993
NCI-G00-1812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.