Phase 3
Completed N=768
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00457691 ↗Enrolled (actual)
768
Serious AEs
36.8%
Results posted
Jun 2011
Primary outcomePrimary: Progression-free Survival (PFS) — 33.6; 36.6 Weeks — p=0.8072
Summary
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
33.6; 36.6 | 0.8072 |
| SECONDARY Overall Survival (OS) |
87.9; 85.9 | 0.9163 |
| SECONDARY Number of Participants With Overall Confirmed Objective Response |
124; 128 | — |
| SECONDARY Duration of Response (DR) |
30.1; 39.0 | — |
| SECONDARY Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score |
1.7; 0.4; 0.8; 0.9; 1.0; 1.8 | — |
| SECONDARY Change From Baseline in MDASI-GI Symptom Interference Score |
0.0; -1.3; -0.1; -1.7; 0.2; -1.2 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire |
0.02; 0.04; 0.02; 0.04; 0.02; 0.03 | — |
| SECONDARY Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS) |
1.0; 3.3; 1.7; 4.3; 1.8; 6.6 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
- Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
- Adequate organ function defined by blood test.
Exclusion Criteria
- History of another primary cancer in the last 3 years.
- Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
- History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.
Data sourced from ClinicalTrials.gov (NCT00457691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.