Clinical trial · Interventional
Colorectal Cancer RECHALLENGE
A Phase II Study of Modified FOLFOX-6 Chemotherapy as First-line Treatment of Metastatic Colorectal Cancer in Patients Who Have Received Oxaliplatin-based Adjuvant Chemotherapy
NCT00988897CI-TRIAL-00002920withdrawnPhase 2ClinicalTrials.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)
Primary Objective: * To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy. Secondary Objective: * To evaluate other measures of tumour's responses and safety.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FLUOROURACIL (5-FU) | Drug | Fluorouracil | ALIAS |
| BEVACIZUMAB | Drug | Bevacizumab | ALIAS |
| LEUCOVORIN (LV) | Drug | Leucovorin | ALIAS |
| OXALIPLATIN (SR96669) | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.
- interventionNames
- Drug: OXALIPLATIN (SR96669)
- Drug: 5-FLUOROURACIL (5-FU)
- Drug: LEUCOVORIN (LV)
- Drug: BEVACIZUMAB
Primary outcomes (1)
- measure
- Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria.
- timeFrame
- At the end of 8 cycles or end of treatment which occurs first.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically proven adenocarcinoma of colon or rectum * Measurable metastatic disease, either inoperable, or residual after surgical procedure * No prior chemotherapy for metastatic disease * For colon cancer: prior adjuvant chemotherapy with oxaliplatin that ended at least 12 months prior to enrollment. * For rectal cancer: at least 12 months since prior use of oxaliplatin in neoadjuvant or adjuvant chemotherapy * Adequate liver and kidney function: * Total bilirubin inferior to 1.5 ULN * Serum Creatinine inferior to 150 umol/L * Creatinine clearance (ClCr) \> 30 mL/min * ALT / AST inferior to 3 ULN * Adequate hematological function * Neutrophils \> or equal 1.5 x 109/L * Platelets \> or equal 100 x 109/L Exclusion criteria: * Metastatic disease presenting without prior adjuvant chemotherapy * Metastatic disease presenting after non-oxaliplatin-containing adjuvant chemotherapy * Peripheral sensory or motor neuropathy \> grade 1 * Eastern Cooperative Oncology Group (ECOG) Performance status \> 2 * Other active malignancy * History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to Leucovorin or to any ingredients in the formulations or the containers * Patients who are pregnant, or breast-feeding * Patients with severe renal impairment (ClCr \< 30 mL/min) * Pernicious anemia or other megaloblastic anemia with Vitamin B12 deficiency * Patients with reproductive potential not implementing accepted and effective method of contraception (the definition of effective method of contraception will be based on the investigators' judgment) * Participation in another clinical trial with any investigational drug within 30 days prior to study screening * For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with know hypersensitivity to any components of the product and to Chinese hamster ovary cell product or other recombinant human or humanized antibodies * Presence of any symptoms suggesting brain metastasis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.