Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

NCT00515190 | Unknown Phase 2

• 2 other identifiers: NCCCTS-07-26582-31-920-1609
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.

Conditions

Stomach Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survial in the two treatment arms

  During study period

Secondary Outcomes (1)

• Response rate, toxicity, duration of response, time to progression, Quality of life in the two treatment arms,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics, treatment efficacy and toxicity

  During study period

Study Arms (2)

A

ACTIVE COMPARATOR

(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal.

Drug: S-1,oxaliplatin

B

ACTIVE COMPARATOR

(intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.

Drug: S-1,oxaliplatin

Interventions

S-1,oxaliplatin DRUG

Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal. Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.

A; B

Eligibility Criteria

• Age: 18 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 and/or metastatic disease
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
• No prior treatment for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior oxaliplatin is not allowed)
• Adequate major organ function including the following: Hematopoietic function: ANC \>= 1,500/mm3, Platelet \>= 100,000/mm3, Hepatic function: serum bilirubin =\< 1.5 x ULN, AST/ALT levels =\< 2.5 x ULN (=\< 5 x ULN if liver metastases are present)Renal function: serum creatinine =\< 1.5 x ULN
• Patients should sign a written informed consent before study entry

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
• Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
• Prior and/or current history of peripheral neuropathy
• grade 1 NCI-CTCAE version 3.0
• Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory 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
• Females with a positive or no pregnancy test (within 7 days before treatment start) until childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy)
• Subjects with reproductive potential not willing to use an effective method of contraception
• Lactating women
• Known dihydropyrimidine dehydrogenase deficiency
• Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.

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

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

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

Se Youn Jang, M.S.

CONTACT

+82-+31-920-0667; jj96smc@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: August 10, 2007
• First Posted: August 13, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 7, 2008

Record last verified: 2007-12

Locations

KR (1)