Clinical trial · Interventional
GTI-2040, Oxaliplatin, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors
A Phase I Study of GTI-2040 in Combination With Oxaliplatin and Capecitabine in Patients With Advanced Metastatic Solid Tumors
NCT00084643CI-TRIAL-00009842completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| GTI-2040 | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (GTI-2040, capecitabine, oxaliplatin)
- description
- 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.
- interventionNames
- Biological: GTI-2040
- Drug: oxaliplatin
- Drug: capecitabine
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- MTD of the combination of GTI-2040, oxaliplatin and capecitabine based on the incidence of dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0
- timeFrame
- 21 days
- description
- Adverse events will be summarized by grade, attribution, and organ system. Hematological and clinical chemistry laboratory results will be included in the adverse event summary.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.