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

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