A Phase I Study of GTI-2040 in Combination With Oxaliplatin and Capecitabine in Patients With Advanced Metastatic Solid Tumors

Fecha de inicio: 1 de mayo de 2004

Inclusion Criteria: * Patients must have locally advanced or metastatic colorectal cancer that is not amenable to surgical treatment; selected patients with advanced disease in incurable cancers of other types may be considered * Patients must have histological or cytological proof of malignancy * Patients must have had at least one standard prior chemotherapy for locally advanced or metastatic disease with no prior oxaliplatin containing regimen; patients who relapse within 12 months of adjuvant therapy are eligible * Karnofsky performance status of \>= 60% * Absolute neutrophil count \> 1500/ul * Platelets \> 100,000/ul * Total bilirubin within institutional normal limits * AST (SGOT)/ALT (SGPT) within 2.5 x institutional normal limits * Alkaline phosphatase within 2.5x institutional normal limits * Creatinine within institutional normal limits or a calculated creatinine clearance \> 60 ml/min * Patients should have no greater than grade 1 neuropathy (CTCAE v3.0) * Ability to understand and the willingness to sign a written IRB approved consent document * Measurable disease not required * Previous chemotherapy must have been completed \> 21 days before treatment on this study (\> 6 weeks for mitomycin-c or nitrosoureas) * Life expectancy of at least 12 weeks Exclusion Criteria: * Active or chronic hepatitis B or C * HIV positive patients receiving antiviral therapy because of possible pharmacokinetic interactions * Uncontrolled intercurrent illnesses including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia * Pregnant or nursing women are excluded due to the potential for teratogenic effects and for potential deleterious effects on the infant; woman of childbearing age and men must practice an effective form of contraception * Patients with known brain metastasis are excluded due their poor prognosis and due to possible neurologic sequelae that could confound the evaluation of the investigational treatment * Patients requiring anticoagulation are excluded as polyanions are known to inhibit clotting mechanisms and phosphorothioate oligonucleotide may act in a similar mechanism; patients receiving low dose prophylactic Coumadin (1 mg/day) may be included * Medical, social, of psychological factors that would interfere with consent and follow-up * Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process