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Completed

NCT Number: NCT00553696

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

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aichi cancer center central hospital / Medical Oncology, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

S-1

Drug

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

Sunitinib

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

Important dates

Study start
2007
Primary completion
2009
Study completion
2014
First posted
Nov 5, 2007
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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