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

NCT00580359 | Unknown Phase 2

• 1 other identifier: NCCCTS-07-263
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (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

  During Chemotherapy

Secondary Outcomes (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

  During study period

Study Arms (2)

A

ACTIVE COMPARATOR

S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)

Drug: S-1, capecitabine

B

ACTIVE COMPARATOR

Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)

Drug: S-1, capecitabine

Interventions

S-1, capecitabine DRUG

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

A; B

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
• 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
• 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
• 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)
• 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:

You may not qualify if:

• 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
• Patients with active (significant or uncontrolled) gastrointestinal bleeding
• 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
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
• Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
• History of or current brain metastases
• Psychiatric disorder that would preclude compliance
• Known dihydropyrimidine dehydrogenase deficiency
• Patients receiving a concomitant treatment with drugs interacting with S-1 or capecitabine such as flucytosine, phenytoin, warfarin, lamivudine, or allopurinol et al.
• Patients with known active infection with HIV, HBV, or HCV
• Major surgery within 4 weeks of start of study treatment, without complete recovery
• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

S 1 (combination); Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sook Ryun Park, M.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sook Ryun Park, M.D.

CONTACT

+82-31-920-1609; sukryun73@ncc.re.kr

So Yun Park, MS

CONTACT

+82-31-920-2309; tomongmong@naver.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 24, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: January 8, 2008

Record last verified: 2007-12

Locations

KR (1)