NCT00004193

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jan 1999

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

January 21, 2000

Last Update Submit

April 10, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline to survival

Secondary Outcomes (1)

  • Determine the safety profile of this regimen in these patients.

    Baseline to 1 year

Study Arms (1)

ISIS 2503

EXPERIMENTAL

patients who have metastatic and/or locally recurrent colorectal cancer

Drug: ISIS 2503

Interventions

ISIS 2503DRUG
ISIS 2503

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

ISIS 2503

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mansoor N. Saleh, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

August 5, 2004

Study Start

January 1, 1999

Primary Completion

November 1, 2000

Study Completion

November 1, 2000

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

US(1)