Back to resultsStudy Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
sunitinib malate
capecitabine
cisplatin
sunitinib malate
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)
Cmax of CAP
Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)
Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)
Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)
Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)
Cmin of CAP
Cmin of 5'DFCR
Cmin of 5'DFUR
Cmin of 5-FU
Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)
Tmax for CAP
Tmax for 5'DFCR
Tmax for 5'DFUR
Tmax for 5-FU
Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for CAP
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for 5'DFCR
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for 5'DFUR
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for 5-FU
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)
Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU
AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast for 5'DFCR
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast for 5'DFUR
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast for 5-FU
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Percentage of Participants With Objective Response
Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Duration of Response (DR)
DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.
Progression-Free Survival (PFS)
PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00555620
Brief Title
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
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Oxaliplatin is given 110mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
Sutent
Intervention Description
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin is given 80mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Description
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
Primary Outcome Measure Information:
Title
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Description
Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.
Time Frame
Baseline up to Day 21
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)
Time Frame
Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Title
Cmax of CAP
Time Frame
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)
Title
Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)
Time Frame
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)
Title
Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)
Time Frame
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)
Title
Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)
Time Frame
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)
Title
Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)
Time Frame
Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Title
Cmin of CAP
Time Frame
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)
Title
Cmin of 5'DFCR
Time Frame
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)
Title
Cmin of 5'DFUR
Time Frame
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)
Title
Cmin of 5-FU
Time Frame
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)
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)
Time Frame
Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Title
Tmax for CAP
Time Frame
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)
Title
Tmax for 5'DFCR
Time Frame
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)
Title
Tmax for 5'DFUR
Time Frame
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)
Title
Tmax for 5-FU
Time Frame
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)
Title
Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Title
t1/2 for CAP
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
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)
Title
t1/2 for 5'DFCR
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
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)
Title
t1/2 for 5'DFUR
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
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)
Title
t1/2 for 5-FU
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
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)
Title
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)
Description
Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.
Time Frame
Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU
Description
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame
Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Title
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU
Description
AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)
Time Frame
Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
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)
Title
AUClast for 5'DFCR
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
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)
Title
AUClast for 5'DFUR
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
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)
Title
AUClast for 5-FU
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
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)
Title
Percentage of Participants With Objective Response
Description
Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame
Baseline, Day 21 of every even-numbered cycle up to 15 months
Title
Duration of Response (DR)
Description
DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.
Time Frame
Baseline up to Month 15
Title
Progression-Free Survival (PFS)
Description
PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Time Frame
Baseline up to Month 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24091982
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181126&StudyName=Study%20Of%20Sunitinib%20%20In%20Combination%20With%20Cisplatin/Capecitabine%20Or%20Oxaliplatin/Capecitabine%20In%20Patients%20With%20Advanced%20Gastric%20Cancer
Description
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Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
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