Phase 1
Completed N=76
Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Source: ClinicalTrials.gov NCT00555620 ↗Enrolled (actual)
76
Serious AEs
31.6%
Results posted
Sep 2011
Primary outcomePrimary: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) — 1; 0; 3; 2 participants
Summary
The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have 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; 3; 2; 2; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) |
40.1; 69.7; 46.5; 14.0; 23.7; 16.6 | — |
| SECONDARY Cmax of CAP |
7000; 2051; 11681; 20491; 1989; 16276 | — |
| SECONDARY Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR) |
4800; 3352; 8017; 5500; 2267; 8036 | — |
| SECONDARY Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR) |
4010; 2891; 7166; 6259; 2074; 10082 | — |
| SECONDARY Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU) |
176; 165; 495; 552; 153; 866 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) |
29.0; 49.2; 30.2; 11.9; 18.7; 11.1 | — |
| SECONDARY Cmin of CAP |
24.8; 0.0; 0.0; 32.0; 0.0; 0.0 | — |
| SECONDARY Cmin of 5'DFCR |
11.1; 13.0; 55.60; 50.5; 0.00; 0.00 | — |
| SECONDARY Cmin of 5'DFUR |
0.0; 2.4; 34.4; 33.5; 0.0; 0.0 | — |
| SECONDARY Cmin of 5-FU |
0.0; 0.0; 0.8; 0.0; 0.0; 0.0 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) |
4.0; 8.0; 8.0; 9.0; 8.0; 6.0 | — |
| SECONDARY Tmax for CAP |
4.3; 2.0; 0.5; 0.3; 2.0; 0.4 | — |
| SECONDARY Tmax for 5'DFCR |
4.3; 2.0; 0.6; 0.4; 3.0; 0.5 | — |
| SECONDARY Tmax for 5'DFUR |
4.5; 2.0; 0.8; 0.4; 3.0; 0.5 | — |
| SECONDARY Tmax for 5-FU |
4.5; 2.0; 0.6; 0.4; 3.0; 0.5 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662) |
— | — |
| SECONDARY t1/2 for CAP |
0.3; 0.3; 0.4; 0.4; 0.5; 0.4 | — |
| SECONDARY t1/2 for 5'DFCR |
0.7; 1.0; 0.8; 0.7; 1.1; 0.8 | — |
| SECONDARY t1/2 for 5'DFUR |
0.7; 1.0; 0.7; 0.6; 1.0; 0.7 | — |
| SECONDARY t1/2 for 5-FU |
0.8; 1.2; 0.6; 0.6; 1.1; 0.6 | — |
| SECONDARY Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) |
844; 1420; 902; 321; 524; 327 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU |
7480; 2828; 8069; 9200; 8853; 11467 | — |
| SECONDARY Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU |
25435; 2663; 8865; 15522; 7087; 10091 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP |
7555; 2899; 7373; 13532; 3157; 8213 | — |
| SECONDARY AUClast for 5'DFCR |
12815; 8028; 11229; 8614; 6464; 9776 | — |
| SECONDARY AUClast for 5'DFUR |
8855; 5658; 8951; 8500; 4829; 10017 | — |
| SECONDARY AUClast for 5-FU |
355; 291; 506; 688; 350; 854 | — |
| SECONDARY Percentage of Participants With Objective Response |
16.7; 42.9; 46.7; 43.5; 0; 45.5 | — |
| SECONDARY Duration of Response (DR) |
14.1; 6.3; 10.5; 5.9; 6.3 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.2; 6.6; 6.4; 8.0; 2.8; 5.5 | — |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of stomach cancer
- advanced stomach cancer of stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and sign an informed consent document
Exclusion Criteria
- prior chemotherapy for the stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
Data sourced from ClinicalTrials.gov (NCT00555620). 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.