Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

ISIS 3521 or ISIS 5132 in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over		CAN-NCIC-IND112 IND112

Objectives

I.  Determine the efficacy of ISIS 3521 and ISIS 5132 in patients with locally 
advanced or metastatic colorectal cancer.

II.  Determine the tolerability and quantitative toxicity of ISIS 3521 and 
ISIS 5132 in this patient population.

Entry Criteria

Disease Characteristics:

Histologically documented metastatic and/or locally advanced carcinoma of the
colon or rectum that is incurable with standard therapy

Bidimensionally measurable disease
 Indicator lesions must be at least 4 cm2 and no greater than 40 cm2 by CT
  scan

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy for metastatic or locally advanced disease
 At least 12 months since adjuvant chemotherapy with or without radiotherapy
 No other concurrent chemotherapy 

Endocrine therapy:
 No concurrent steroids

Radiotherapy:
 Recovered from prior radiotherapy
 At least 4 weeks since radiotherapy to at least 20% of bone marrow

Surgery:
 Not specified

Other:
 No concurrent anticoagulant therapy

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-1

Life expectancy:
 At least 12 weeks

Hematopoietic:
 Granulocyte count at least 1500/mm3
 Platelet count at least 100,000/mm3
 No known bleeding disorder
 
Hepatic:
 PT/PTT within normal range (except when elevated due to therapeutic coumadin
  treatment)
 Bilirubin no greater than 2 times upper limit of normal (ULN)
 AST less than 5 times ULN

Renal:
 Creatinine no greater than 2 times ULN
 
Cardiovascular:
 No significant cardiac dysfunction

Neurologic:
 No history of significant neurologic disorder  
  
Other:
 At least 5 years since prior malignancy and no evidence of recurrence
 Not pregnant or nursing
 Fertile patients must use effective contraception
 No active uncontrolled infection
 No history of significant psychiatric disorder

Expected Enrollment

Approximately 30 patients will be accrued for this study within 9-12 months.

Outline

This is a randomized study.

Patients receive a 21-day intravenous infusion of ISIS 3521 or ISIS 5132.  
Treatment is repeated every 4 weeks in the absence of unacceptable toxicity or 
disease progression.

Patients are followed at 4 weeks intervals until disease progression, then 
every 3 months.

Cripps MC, Figueredo AT, Oza AM, et al.: Phase II randomized study of ISIS 3521 and ISIS 5132 in patients with locally advanced or metastatic colorectal cancer: a National Cancer Institute of Canada clinical trials group study. Clin Cancer Res 8 (7): 2188-92, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

M. Christine Cripps, MD, FRCPC, Protocol chair		Ph: 613-737-7700 ext. 70176; 888-627-5346 Email: ccripps@ottawahospital.on.ca