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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

baseline to survival

Safety Issue:

No

Principal Investigator

Mansoor N. Saleh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067434

NCT ID:

NCT00004193

Start Date:

January 1999

Completion Date:

November 2000

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294