GTI-2040, Oxaliplatin, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIIC Colon Cancer
About this trial
This is an interventional treatment trial for Recurrent Colon Cancer
Eligibility Criteria
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
Sites / Locations
- City of Hope
Arms of the Study
Arm 1
Experimental
Treatment (GTI-2040, capecitabine, oxaliplatin)
Patients receive GTI-2040 IV continuously on days 1-14, oral capecitabine twice daily on days 2-15, and oxaliplatin IV over 2 hours on day 2 of the first course. In all subsequent courses, capecitabine is administered on days 1-14, oxaliplatin is administered on day 1, and GTI-2040 is administered as in course 1. Courses repeat every 21 days in the absence of disease progression and unacceptable toxicity.