Clinical trial · Interventional
Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal Cancer
A Phase I Study of Sorafenib (Nexavar®) in Combination With FOLFIRI as First Line Therapy for Metastatic Colorectal Cancer
NCT00780169CI-TRIAL-00010272completedPhase 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)
The purpose of this study is to assess the safety, the maximum tolerated dose and the recommended dose for phase II studies of a chemotherapy-combination of sorafenib, irinotecan, and 5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) as first-line treatment for metastatic colorectal cancer.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib + FOLFIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sorafenib +FOLFIRI
- description
- This is a Phase I safety study. There is only one arm of FOLFIRI administered every 14 days (2 week schedule) and sorafenib administered orally, twice daily continuously. First cycle sorafenib began at day +2 to FOLFIRI.
- interventionNames
- Drug: sorafenib + FOLFIRI
Primary outcomes (1)
- measure
- Toxicity spectrum of Sorafenib (MTD, DLT) and the recommended dose (RD) for phase II studies of Sorafenib when combined with FOLFIRI in first line patients with metastatic colorectal cancer (mCRC)
- timeFrame
- each cycle - 4 weeks; continuous monitoring of AEs
Secondary outcomes (3)
- measure
- Pharmacokinetics of Irinotecan in the presence of Sorafenib
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic colorectal cancer * Histopathological verification of the primary tumor * Measurable disease according to RESIST criteria * Response Evaluation Criteria in Solid Tumors (ECOG) performance status ≤ 2 * Age \> 18 years. * Women of childbearing potential must have had a negative pregnancy test within 7 days prior to start of treatment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * Patients may have had prior adjuvant chemotherapy with fluoropyrimidines WITHOUT pelvic radiotherapy. * Radiation: Patients may have had prior palliative radiation therapy to NO more than 50% of the areas bearing of bone marrow stores. * Adequate organ and marrow function : Hemoglobin \> 9.0 g/dl; absolute neutrophil count (ANC) \>1,500/mm3; absolute granulocyte count(AGC) \> 1.5 x 109 /L; Platelets \> 100 x 109 /L; Serum creatinine and creatinine clearance within upper normal limit; Bilirubin \< 1.0 x upper normal limit, \< 2.5 x upper normal limit if documented liver metastases; aspartate aminotransferase (AST) \< 2.5 x upper normal limit, \< 5 x upper normal limit if documented liver metastases * Life expectancy \> 3 months * Informed consent Exclusion Criteria: * Previous or concurrent malignancies * Patients with central nervous system (CNS) metastases * Pregnant or lactating women * Concurrent treatment with other experimental drugs or anticancer therapy * Previous chemotherapy for advanced and/or metastatic disease * Previous adjuvant therapy with irinotecan or targeted agents * Previous Sorafenib therapy * Previous full dose curative pelvic radiotherapy * History of cardiovascular disease, cerebral ischemia infarction or hemorrhage, Gilbert's disease, HIV positivity * Unable to be compliant with the procedures in the protocol * Currently use prohibited medications
References
Publications (0)
Data not yet available
No reference posted for this study.