S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00343668
• Other study ID #: KCSG-ST05-02
• Status: Recruiting
• Phase: Phase 2
• First received: June 22, 2006
• Last updated: May 25, 2010
• Start date: September 2005
• Est. completion date: July 2008

Study information

• Verified date: June 2006
• Source: Korean Cancer Study Group
• Contact: Baek-Yeol Ryoo, M.D., Ph.D.
• Phone: +82-2-970-1208
• Email: ryooby[@]kcch.re.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pathologically proven unresectable adenocarcinoma of stomach

• With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)

• Age 18 to 70 years old

• Estimated life expectancy of more than 3 months

• ECOG performance status of 2 or lower

• Adequate bone marrow function(absolute neutrophil count [ANC] =1,500/µL, hemoglobin =9.0 g/dL,and platelets =100,000/µL)

• Adequate kidney function (serum creatinine < 1.5 mg/dL)

• Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL)

• No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)

• No prior radiation therapy for at least 4 weeks before enrollment in the study

Exclusion Criteria:

• Other tumor type than adenocarcinoma

• Central nervous system (CNS) metastases or prior radiation for CNS metastases

• Gastric outlet obstruction or intestinal obstruction

• Evidence of gastrointestinal bleeding

• The patient has bony lesions as the sole evaluable disease.

• Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• Other serious illness or medical conditions

• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry

• History of significant neurologic or psychiatric disorders including dementia or seizures

• Active uncontrolled infection

• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study

• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

• concomitant drug medication; The following drugs cause drug interaction with S-1.

i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1, irinotecan
S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeolanam-do
Korea, Republic of	Inha University hospital	Inchon
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeonbuk
Korea, Republic of	Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine	Seoul
Korea, Republic of	Korea Institute of radiological and Medical Sciences	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		best response	Yes
Secondary	treatment-related toxicities		during treatment	Yes