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

Stomach Neoplasms Clinical Trial

Official title:

A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555620
• Other study ID #: A6181126
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2007
• Last updated: January 7, 2013
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• capecitabine
Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
• 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.
• sunitinib malate
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
• capecitabine
Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
• 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.
• sunitinib malate
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Goyang	Gyeonggi
Korea, Republic of	Pfizer Investigational Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Day 21	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)		Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)	No
Secondary	Cmax of CAP		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)	No
Secondary	Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)		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)	No
Secondary	Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)		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)	No
Secondary	Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)		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)	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)		Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)	No
Secondary	Cmin of CAP		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)	No
Secondary	Cmin of 5'DFCR		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)	No
Secondary	Cmin of 5'DFUR		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)	No
Secondary	Cmin of 5-FU		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)	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)		Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)	No
Secondary	Tmax for CAP		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)	No
Secondary	Tmax for 5'DFCR		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)	No
Secondary	Tmax for 5'DFUR		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)	No
Secondary	Tmax for 5-FU		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)	No
Secondary	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.	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)	No
Secondary	t1/2 for CAP	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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)	No
Secondary	t1/2 for 5'DFCR	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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)	No
Secondary	t1/2 for 5'DFUR	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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)	No
Secondary	t1/2 for 5-FU	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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)	No
Secondary	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.	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]: CAP, 5'DFCR, 5'DFUR, and 5-FU	AUC (0 - 8) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)	No
Secondary	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)	Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)	No
Secondary	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)	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)	No
Secondary	AUClast for 5'DFCR	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	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)	No
Secondary	AUClast for 5'DFUR	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	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)	No
Secondary	AUClast for 5-FU	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	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)	No
Secondary	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.	Baseline, Day 21 of every even-numbered cycle up to 15 months	No
Secondary	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.	Baseline up to Month 15	No
Secondary	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.	Baseline up to Month 15	No

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