Status:
COMPLETED
GTI-2040, Oxaliplatin, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Colon Cancer
Recurrent Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of capecitabine when given together with GTI-2040 and oxaliplatin in treating patients with locally advanced or metastatic colorectal canc...
Detailed Description
PRIMARY OBJECTIVES: I. To establish the maximum tolerated (MTD) of a 21 day cycle of capecitabine given orally twice daily for 14 days in combination with oxaliplatin given intravenously on day 1 and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00084643
Start Date
May 1 2004
Last Update
March 27 2013
Active Locations (1)
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1
City of Hope
Duarte, California, United States, 91010