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Completed

NCT Number: NCT00555672

Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of stomach cancer
  • advanced stomach cancer stage IV
  • adequate blood chemistry, blood counts and kidney function
  • willing to participate to study requirements and to sign an informed consent document

Exclusion criteria

  • prior chemotherapy for stomach cancer in its advanced stage
  • excessive toxicities related to prior therapies
  • pregnant or breastfeeding patients

Treatment and study plan

5-fluorouracil

Drug

5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

Cisplatin

Drug

Cisplatin is given 80 mg/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.

Sunitinib Malate

Drug

sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

Primary outcomes

  1. Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

    Time frame: Cycle 1 (Baseline to Day 21)

    The incidence of DLTs assessed during the first cycle (21 days).

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)

  2. Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]

    Time frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)

    Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)

    Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).

  4. Steady State Concentration (Css) of 5-Fluorouracil (5-FU)

    Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)

    Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).

  5. Infusion Rate (Zero Order) (R0) of 5-FU

    Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)

    Infusion rate of 5-FU equals total dose divided by infusion time.

  6. Clearance (CLss) of 5-FU

    Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)

    Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).

  7. Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU

    Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)

    Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).

  8. Number of Participants With Objective Response

    Time frame: Baseline, Day 21 of every even-numbered cycle up to 15 Months

    Number 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 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.

  9. Duration of Response (DR)

    Time frame: Baseline up to Month 15

    Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.

  10. Progression-Free Survival (PFS)

    Time frame: Baseline up to Month 15

    Median time (50%) 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. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 9, 2007
Registry last updated
Dec 19, 2011

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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