ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer

April 10, 2013 updated by: University of Alabama at Birmingham

Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-ras, in Patients With Advanced Colorectal Cancer

RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer.

PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic and/or locally recurrent colorectal cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the response rate, duration of response, and time to progression in patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503, an antisense inhibitor of H-ras. II. Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive ISIS 2503 IV continuously for 14 days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 1 year.

Study Type

Interventional

Enrollment (Anticipated)

25

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Comprehensive Cancer Center

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

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven metastatic and/or locally recurrent adenocarcinoma of the colon or rectum that is not expected to be cured with standard therapy Patients who previously underwent definitive surgical resection and subsequently develop metastatic disease should have diagnosis reconfirmed with new histologic or cytologic specimen if: More than 5 years have elapsed since primary surgery OR Primary tumor was stage I or II At least 1 measurable lesion (2 cm or more in widest diameter) by CT or MRI scan No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dl Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No second malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy with or without radiotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to nonindicator lesion allowed and recovered See Chemotherapy Surgery: See Disease Characteristics Other: No concurrent approved cancer therapy or other experimental therapy

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ISIS 2503
patients who have metastatic and/or locally recurrent colorectal cancer
Drug: ISIS 2503

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the response rate, duration of response, and time to progression in patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503, an antisense inhibitor of H-ras
Time Frame: baseline to survival
baseline to survival

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the safety profile of this regimen in these patients.
Time Frame: Baseline to 1 year
Baseline to 1 year

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mansoor N. Saleh, MD, University of Alabama at Birmingham

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

January 1, 1999

Primary Completion (Actual)

November 1, 2000

Study Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

August 4, 2004

First Posted (Estimate)

August 5, 2004

Study Record Updates

Last Update Posted (Estimate)

April 12, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067434
  • UAB-9860
  • ISIS-2503-CS6
  • NCI-G99-1649

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.

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