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

NCT ID: NCT00555620

Last Updated: 2013-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

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

oxaliplatin

Intervention Type DRUG

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

Intervention Type DRUG

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

B

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

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

cisplatin

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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capecitabine

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

Intervention Type DRUG

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.

Intervention Type DRUG

sunitinib malate

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

Intervention Type DRUG

capecitabine

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

Intervention Type DRUG

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.

Intervention Type DRUG

sunitinib malate

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

Intervention Type DRUG

Other Intervention Names

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Sutent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Goyang-si, Gyeonggi-do, South Korea

Site Status

Pfizer Investigational Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee KW, Park SR, Oh DY, Park YI, Khosravan R, Lin X, Lee SY, Roh EJ, Valota O, Lechuga MJ, Bang YJ. Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. Invest New Drugs. 2013 Dec;31(6):1547-58. doi: 10.1007/s10637-013-0032-y. Epub 2013 Oct 4.

Reference Type DERIVED
PMID: 24091982 (View on PubMed)

Related Links

Other Identifiers

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A6181126

Identifier Type: -

Identifier Source: org_study_id

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