S-1 vs Capecitabine in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and < 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in ³65 years and <70 years, ECOG performance status 2 versus 3.

• S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
• Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.

Condition or disease	Intervention/treatment	Phase
Stomach Neoplasms	Drug: S-1, capecitabine	Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	96 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
Study Start Date :	May 2007
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	June 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: A; S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)	Drug: S-1, capecitabine; S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression
Active Comparator: B; Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)	Drug: S-1, capecitabine; S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer [ Time Frame: During Chemotherapy ]

Secondary Outcome Measures :

1. the duration of response, time to progression, progression-free survival,overall survival,the safety profiles,the quality of life,the CYP2A6 genetic polymorphism and its association with clinical outcomes in patients treated with S-1 [ Time Frame: During study period ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
2. Age of 70-85 years with Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or age ≥65 and <70 with ECOG performance status ≥ 2

3. Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) Measurable lesions:

   • Lesions that can be accurately measured in at least one dimension by any of the following:

     • Computed tomography (CT) of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT
     • Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
4. No prior chemotherapy for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant chemotherapy is allowed at least 6 months has relapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the therapy; prior S-1 or capecitabine is not allowed)

5. Adequate major organ function including the following:

   • Hematopoietic function:

     • absolute neutrophil count (ANC)≥1,500/mm3,
     • Platelet ≥ 100,000/mm3,

   • Hepatic function:

     • serum bilirubin =< 1.5 x upper limit of normal (ULN),
     • AST/ALT levels =< 2.5 x ULN ( 5 x ULN if liver metastases are present)

   • Renal function:

     • serum creatinine =< 1.5 x ULN
6. Patients should sign a written informed consent before study entry

Exclusion Criteria:

1. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
2. Patients with active (significant or uncontrolled) gastrointestinal bleeding

3. Inadequate cardiovascular function:

   • New York Heart Association class III or IV heart disease
   • Unstable angina or myocardial infarction within the past 6 months
   • History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
4. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
5. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
6. History of or current brain metastases
7. Psychiatric disorder that would preclude compliance
8. Known dihydropyrimidine dehydrogenase deficiency
9. Patients receiving a concomitant treatment with drugs interacting with S-1 or capecitabine such as flucytosine, phenytoin, warfarin, lamivudine, or allopurinol et al.
10. Patients with known active infection with HIV, HBV, or HCV
11. Major surgery within 4 weeks of start of study treatment, without complete recovery
12. Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Sook Ryun Park, M.D.	+82-31-920-1609	sukryun73@ncc.re.kr
Contact: So Yun Park, MS	+82-31-920-2309	tomongmong@naver.com

Locations

Korea, Republic of
National Cancer Center Korea	Recruiting
Goyang, Gyeonggi, Korea, Republic of
Contact: Sook Ryun Park, M.D +82-31-920-1609 sukryun73@ncc.re.kr
Contact: So Yun Park, MS +82-31-920-2307 tomongmong@naver.com
Sub-Investigator: Noe Kyeong Kim, M.D
Sub-Investigator: Young Iee Park, M.D
Sub-Investigator: Byung-Ho Nam, M.D
Sub-Investigator: Hye Suk Han, M.D

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator:	Sook Ryun Park, M.D	National Cancer Center, Korea

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sook Ryun Park, M.D., National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00580359 History of Changes
Other Study ID Numbers:	NCCCTS-07-263
First Posted:	December 24, 2007
Last Update Posted:	January 8, 2008
Last Verified:	December 2007

Keywords provided by National Cancer Center, Korea:

Stomach Neoplasms; Secondary; Combination chemotherapy; S-1; Capecitabine

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases	Stomach Diseases; Capecitabine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents