Clinical trial · Interventional
Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients
NCT00040820CI-TRIAL-00004513completedN/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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy * Locally advanced OR * Metastatic disease * Patients who progressed on a non-oxaliplatin-containing (control) arm in Sanofi-Synthelabo second-line regulatory trials OR * Patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens * Documented radiological disease progression after last anticancer treatment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 75,000/mm3 Hepatic: * SGOT or SGPT no greater than 6 times upper limit of normal (ULN) * Bilirubin no greater than 2 mg/dL * Alkaline phosphatase no greater than 5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * Adequate organ function and medically stable * No known concurrent peripheral neuropathy * Absence of deep tendon reflexes as the sole neurologic abnormality is allowed PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 30 days since prior chemotherapy * No prior oxaliplatin-based chemotherapy * No other concurrent investigational chemotherapy agents Endocrine therapy: * Not specified Radiotherapy: * At least 30 days since prior radiotherapy Surgery: * See Disease Characteristics * At least 30 days since prior major surgical procedure or intervention Other: * At least 30 days since other prior anticancer therapy * No other concurrent anticancer agents * No concurrent participation in any other investigational studies
References
Publications (0)
Data not yet available
No reference posted for this study.