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Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00553696
Recruitment Status : Completed
First Posted : November 5, 2007
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: Cisplatin Drug: S-1 Drug: Sunitinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer
Study Start Date : November 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: A Drug: Cisplatin
Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

Drug: S-1
S-1 80 mg/m2 on days 1-21 of each 28 day cycle

Drug: Sunitinib
Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle




Primary Outcome Measures :
  1. Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Baseline to Week 4) ]
    A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) ]
  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) ]
  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  4. Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) ]
  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) ]
  6. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  7. Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) ]
  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) ]
  9. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  10. Number of Participants With Objective Response [ Time Frame: Baseline up to 739 days ]
    Number of participants with 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 greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.

  11. Number of Participants With Clinical Benefit Response (CBR) [ Time Frame: Baseline up to 739 days ]
    CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.

  12. Duration of Response (DR) [ Time Frame: Baseline up to 739 days ]
    Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).

  13. Progression-Free Survival (PFS) [ Time Frame: Baseline up to 739 days ]
    Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)

  14. Time to Progression (TTP) [ Time Frame: Baseline up to 739 days ]
    Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of gastric cancer
  • Chemonaive patients
  • Adequate organ function

Exclusion Criteria:

  • Patients who meet the contra-indications of S-1 and Cisplatin.
  • Prior chemotherapy failure patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553696


Locations
Japan
Aichi cancer center central hospital / Medical Oncology
Nagoya, Aichi, Japan, 464-8681
Saku Central Hospital, GI Devision
Saku, Nagano, Japan
Shizuoka Cancer Center
Suntougun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00553696     History of Changes
Other Study ID Numbers: A6181127
First Posted: November 5, 2007    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: March 13, 2015
Last Verified: March 2015

Keywords provided by Pfizer:
chemotherapy
combination

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Sunitinib
Cisplatin
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors