Phase 1
Completed N=53
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
Colorectal Cancer · Neoplasms
Source: ClinicalTrials.gov NCT00599924 ↗
Enrolled (actual)
53
Serious AEs
37.7%
Results posted
Dec 2009
Primary outcomePrimary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 4; 9; 5; 12 participants
Summary
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
4; 9; 5; 12; 9; 6 | — |
| SECONDARY Objective Response (OR) |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Sunitinib |
47.13; 61.36; 44.95; 60.24 | — |
| SECONDARY Time to Cmax (Tmax) of Sunitinib |
8.00; 10.00; 7.00; 8.00 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) of Sunitinib |
34.95; 38.23; 30.28; 39.47 | — |
| SECONDARY Clearance (CL/F) of Sunitinib |
41.13; 44.29; 42.40; 49.44 | — |
| SECONDARY Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib |
985.43; 1233.73; 948.40; 1202.50 | — |
| SECONDARY Terminal Phase Half-Life (t1/2) of Sunitinib |
— | — |
| SECONDARY Cmax of SU-012662 (Sunitinib's Metabolite) |
18.95; 22.80; 18.75; 23.44 | — |
| SECONDARY Tmax of SU-012662 (Sunitinib's Metabolite) |
8.00; 10.00; 15.00; 4.00 | — |
| SECONDARY Cmin of SU-012662 (Sunitinib's Metabolite) |
14.45; 15.70; 13.59; 17.68 | — |
| SECONDARY AUC24 for SU-012662 (Sunitinib's Metabolite) |
401.51; 468.79; 395.82; 495.97 | — |
| SECONDARY CL/F of SU-012662 (Sunitinib's Metabolite) |
— | — |
| SECONDARY T1/2 of SU-012662 (Sunitinib's Metabolite) |
— | — |
| SECONDARY Cmax of Free Platinum |
935.25; 634.00; 1043.75; 789.43 | — |
| SECONDARY Tmax of Free Platinum |
2.00; 2.00; 2.00; 2.00 | — |
| SECONDARY Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum |
7459.28; 6490.17; 7942.64; 7092.65 | — |
| SECONDARY T1/2 for Free Platinum |
16.15; 15.60; 18.55; 31.20 | — |
| SECONDARY Cmax of Total Platinum |
2490.00; 2137.14; 2905.00; 2641.43 | — |
| SECONDARY Tmax of Total Platinum |
2.00; 2.00; 2.00; 2.00 | — |
| SECONDARY Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum |
47264.02; 43713.95; 56813.62; 51962.03 | — |
| SECONDARY Steady State Concentration (Css) of Fluorouracil (5-FU) |
567.52; 334.26; 598.86; 647.32 | — |
| SECONDARY Steady State Clearance (CLss) of 5-FU |
284.99; 312.63; 174.51; 201.12 | — |
| SECONDARY Area Under the Curve (AUC) of 5-FU |
— | — |
| SECONDARY Cmax of 5-FU |
— | — |
| SECONDARY T1/2 of Free Platinum, Total Platinum, and 5-FU |
— | — |
| SECONDARY CL/F of Free Platinum, Total Platinum, and 5-FU |
— | — |
| SECONDARY Cmin of Free Platinum, Total Platinum, and 5-FU |
— | — |
| SECONDARY Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) |
— | — |
| SECONDARY Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI |
— | — |
Eligibility Criteria
Inclusion Criteria
- Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
- Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
- Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
- For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting
Data sourced from ClinicalTrials.gov (NCT00599924). 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.