Phase 2
Completed N=71
Study Of Sunitinib With FOLFIRI In Colorectal Cancer
Unresectable or Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00668863 ↗
Enrolled (actual)
71
Serious AEs
45.1%
Results posted
Oct 2011
Primary outcomePrimary: Progression-Free Survival (PFS) — 28.9 weeks
Summary
To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
28.9 | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR) |
36.6 | — |
| SECONDARY Duration of Response (DR) |
28.3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib. |
54.3; 41.8; 15.8; 11.3; 70.0; 53.1 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib |
6; 4; 6 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib |
1161; 346; 1507 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Sunitinib |
32.9 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Irinotecan |
1963; 25.1 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan |
2; 4 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan |
13100; 13800; 274 | — |
| SECONDARY Terminal Phase Elimination Half-life (t1/2) of Irinotecan |
5.36 | — |
| SECONDARY Clearance of Irinotecan |
23.0 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Irinotecan |
160 | — |
| SECONDARY Plasma Concentration at Steady State (Css) of 5-FU |
650 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE). |
71; 32; 70; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
- Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.
Exclusion Criteria
- History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
- Current, recent, or planned participation in an experimental treatment drug study other than this protocol.
Data sourced from ClinicalTrials.gov (NCT00668863). 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.