Clinical trial NCT00555620: Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Official title: A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stomach Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
timeFrame: Baseline up to Day 21
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)
timeFrame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
measure: Cmax of CAP
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)
timeFrame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
measure: Cmin of CAP
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Cmin of 5'DFCR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Cmin of 5'DFUR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Cmin of 5-FU
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)
timeFrame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
measure: Tmax for CAP
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Tmax for 5'DFCR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Tmax for 5'DFUR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Tmax for 5-FU
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)
timeFrame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
measure: t1/2 for CAP
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: t1/2 for 5'DFCR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: t1/2 for 5'DFUR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: t1/2 for 5-FU
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)
timeFrame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU
timeFrame: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
measure: AUClast for 5'DFCR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
measure: AUClast for 5'DFUR
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
measure: AUClast for 5-FU
timeFrame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
measure: Percentage of Participants With Objective Response
timeFrame: Baseline, Day 21 of every even-numbered cycle up to 15 months
measure: Duration of Response (DR)
timeFrame: Baseline up to Month 15
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to Month 15
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lee KW, Park SR, Oh DY, Park YI, Khosravan R, Lin X, Lee SY, Roh EJ, Valota O, Lechuga MJ, Bang YJ. Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. Invest New Drugs. 2013 Dec;31(6):1547-58. doi: 10.1007/s10637-013-0032-y. Epub 2013 Oct 4.