Clinical trial · Interventional
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy
NCT00250029CI-TRIAL-00005541completedN/AClinicalTrials.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)
1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen. 1.2 To determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colonic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen
- timeFrame
- The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients, \>18 years of age, with metastatic/recurrent colorectal cancer are eligible. * Patients must have a life expectancy of at least 12 weeks. * Patients must have a Zubrod performance status of 0-2. * Patients must sign an informed consent. * Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \> 100,000/mm3 and absence of a regular red blood cell transfusion requirement. * Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. * The patient must agree to a biopsy of a sample of tumor for correlative studies. * The patient is an appropriate candidate for oxaliplatin/capecitabine based chemotherapy. * The patient must have measurable disease. Exclusion Criteria: * Patients with symptomatic brain metastases are excluded from this study. * Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception. * Patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * Patients may not have received oxaliplatin previously. * Patients with a prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency, or known hypersensitivity to platinum compounds or any of the components of the study medications.
References
Publications (0)
Data not yet available
No reference posted for this study.