Clinical trial · Interventional
Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC
FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer: a Phase II Trial by the FNF Team.
NCT03222089CI-TRIAL-00032251withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Another study enrolling the similar group of patient are ongoing
Summary
Brief summary (as posted)
A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| GM-CSF | Drug | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Levoleucovorin | Drug | Levoleucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOXIGIL
- description
- The FOLFOXIGIL chemoimmunotherapy regimen is composed by FOLFOXIRI chemotherapy and the immunotherapy of GM-CSF and IL-2. FOLFOXIRI: Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + Levoleucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1, repeated every 2 weeks. GM-CSF 150ug s.c. d3-7; Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity.
- interventionNames
- Drug: Irinotecan
- Drug: Oxaliplatin
- Drug: Levoleucovorin
- Drug: 5-FU
- Drug: GM-CSF
- Drug: IL-2
- type
- ACTIVE_COMPARATOR
- label
- FOLFOXIRI
- description
- Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + Levoleucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1, Repeated every 2 weeks. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histological or cytological documentation of adenocarcinoma of the colon or rectum. * unresectable metastatic disease * age 18 to 75 years * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years * at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration. * no previous chemotherapy or target therapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago). * adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: * Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥9g/ dL. * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN. * Alkaline phosphatase limit ≤ 5x ULN. * Amylase and lipase ≤ 1.5 x the ULN. * Serum creatinine ≤ 1.5 x the ULN. * Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min. Exclusion Criteria: * previous palliative chemotherapy for metastatic disease * previous chemotherapy including irinotecan or oxaliplatin * symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia * active infections * pregnancy or lactation at the time of study entry. * inflammatory bowel disease * major autoimmune diseases * acquired immunosuppression (AIDS or major immunosuppressive agents)
References
Publications (0)
Data not yet available
No reference posted for this study.