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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ISIS 2503
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISIS 2503

Arm Description

patients who have metastatic and/or locally recurrent colorectal cancer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine the safety profile of this regimen in these patients.

Full Information

First Posted
January 21, 2000
Last Updated
April 10, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004193
Brief Title
ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer
Official Title
Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-ras, in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
January 1999 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
November 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ISIS 2503
Arm Type
Experimental
Arm Description
patients who have metastatic and/or locally recurrent colorectal cancer
Intervention Type
Drug
Intervention Name(s)
ISIS 2503
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Determine the safety profile of this regimen in these patients.
Time Frame
Baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansoor N. Saleh, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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

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