Phase 1
Completed N=34
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Source: ClinicalTrials.gov NCT00555672 ↗Enrolled (actual)
34
Serious AEs
35.3%
Results posted
Jan 2011
Primary outcomePrimary: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) — 1; 0 Participants
Summary
The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) |
1; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
16.8; 2.24; 19.0 | — |
| SECONDARY Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)] |
249; 34.0; 283 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
4.00; 4.00; 4.00 | — |
| SECONDARY Steady State Concentration (Css) of 5-Fluorouracil (5-FU) |
593 | — |
| SECONDARY Infusion Rate (Zero Order) (R0) of 5-FU |
68.2 | — |
| SECONDARY Clearance (CLss) of 5-FU |
161 | — |
| SECONDARY Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU |
2372 | — |
| SECONDARY Number of Participants With Objective Response |
6; 3 | — |
| SECONDARY Duration of Response (DR) |
4.17; 4.13 | — |
| SECONDARY Progression-Free Survival (PFS) |
5.2; 6.2 | — |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of stomach cancer
- advanced stomach cancer stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and to sign an informed consent document
Exclusion Criteria
- prior chemotherapy for stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
Data sourced from ClinicalTrials.gov (NCT00555672). 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.