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

Purpose

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.

Condition	Intervention	Phase
Stomach Neoplasms	Drug: 5-fluorouracil Drug: cisplatin Drug: sunitinib malate	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil Malic acid Cisplatin Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Baseline to Day 21) ] [ Designated as safety issue: Yes ]
The incidence of DLTs assessed during the first cycle (21 days).

Secondary Outcome Measures:

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).
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) ] [ Designated as safety issue: No ]
Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).
Steady State Concentration (Css) of 5-Fluorouracil (5-FU) [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ] [ Designated as safety issue: No ]
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).
Infusion Rate (Zero Order) (R0) of 5-FU [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ] [ Designated as safety issue: No ]
Infusion rate of 5-FU equals total dose divided by infusion time.
Clearance (CLss) of 5-FU [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ] [ Designated as safety issue: No ]
Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).
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) ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
Number of Participants With Objective Response [ Time Frame: Baseline, Day 21 of every even-numbered cycle up to 15 Months ] [ Designated as safety issue: No ]
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.
Duration of Response (DR) [ Time Frame: Baseline up to Month 15 ] [ Designated as safety issue: No ]
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.
Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 15 ] [ Designated as safety issue: No ]
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.

Enrollment:	34
Study Start Date:	August 2008
Study Completion Date:	August 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: 5-fluorouracil 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. Drug: cisplatin 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. Drug: sunitinib malate 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.

Arms

Assigned Interventions

Experimental: A

Drug: 5-fluorouracil

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.

Drug: cisplatin

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.

Drug: sunitinib malate

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555672

Locations

Spain
Pfizer Investigational Site
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Madrid, Spain, 28041

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00555672 History of Changes
Other Study ID Numbers:	A6181128
Study First Received:	November 8, 2007
Results First Received:	December 15, 2010
Last Updated:	December 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Sunitinib
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013