Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Pfizer76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasms

Interventions

capecitabineDRUG

Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.

oxaliplatinDRUG

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.

sunitinib malateDRUG

sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Pfizer Investigational Site

Goyang-si, Gyeonggi-do, South Korea

Pfizer Investigational Site

Seongnam-si, Gyeonggi-do, South Korea

Pfizer Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to Day 21

Secondary Outcomes

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.

cisplatinDRUG

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.

sunitinib malateDRUG

sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

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)

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)

t1/2 for CAP

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)

t1/2 for 5'DFCR

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)

t1/2 for 5'DFUR

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)

t1/2 for 5-FU

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)

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.

Time frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

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 - ∞).

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

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)

Time frame: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

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)

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)

AUClast for 5'DFCR

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)

AUClast for 5'DFUR

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)

AUClast for 5-FU

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)

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.

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

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.

Time frame: Baseline up to Month 15

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.

Time frame: Baseline up to Month 15