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Trial record 1 of 1 for:    NCT00555620
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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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ClinicalTrials.gov Identifier: NCT00555620
Recruitment Status : Completed
First Posted : November 8, 2007
Results First Posted : September 5, 2011
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 6, 2007
First Posted Date  ICMJE November 8, 2007
Results First Submitted Date  ICMJE August 4, 2011
Results First Posted Date  ICMJE September 5, 2011
Last Update Posted Date January 14, 2013
Study Start Date  ICMJE May 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline up to Day 21 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
  • determination of maximum tolerated dose [ Time Frame: 10 months ]
  • determination of the safety profile of the combinations [ Time Frame: 10 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Terminal Elimination Half-Life (t1/2) 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) ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • t1/2 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) ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • t1/2 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) ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • t1/2 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) ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • t1/2 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) ]
    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) [ Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose) ]
    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 [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]
    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 [ Time Frame: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]
    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 [ 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) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • AUClast for 5'DFCR [ 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) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • AUClast for 5'DFUR [ 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) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • AUClast for 5-FU [ 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) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Percentage of Participants With Objective Response [ Time Frame: Baseline, Day 21 of every even-numbered cycle up to 15 months ]
    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) [ Time Frame: Baseline up to Month 15 ]
    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) [ Time Frame: Baseline up to Month 15 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
  • anti-tumor activity [ Time Frame: 15 months ]
  • pharmacokinetic analysis [ Time Frame: 10 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Official Title  ICMJE A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE
  • Drug: capecitabine
    Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
  • Drug: oxaliplatin
    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.
  • Drug: sunitinib malate
    sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
    Other Name: Sutent
  • Drug: cisplatin
    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.
  • Drug: sunitinib malate
    sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: capecitabine
    • Drug: oxaliplatin
    • Drug: sunitinib malate
  • Experimental: B
    Interventions:
    • Drug: capecitabine
    • Drug: cisplatin
    • Drug: sunitinib malate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2013)
76
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2007)
60
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555620
Other Study ID Numbers  ICMJE A6181126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP