GTI-2040, Oxaliplatin, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors

Completed · Phase 1

Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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 cancer or other solid tumors. Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. Giving GTI-2040 together with oxaliplatin and capecitabine may kill more tumor cells

Key facts

Study ID: NCT00084643
Run by: National Cancer Institute (NCI)
People needed: 20
Starts: 2004-05-01
Last updated by the study team: 2013-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

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