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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00515190
First received: August 10, 2007
Last updated: December 21, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms
Drug: S-1,oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Overall survial in the two treatment arms [ Time Frame: During study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: During study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 198
Study Start Date: July 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal.
Drug: S-1,oxaliplatin

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.

Active Comparator: 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.
Drug: S-1,oxaliplatin

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent and/or metastatic disease
  2. Age ≥ 18 years
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
  5. 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)
  6. 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
  7. 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. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
  4. Prior and/or current history of peripheral neuropathy

    • grade 1 NCI-CTCAE version 3.0
  5. 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
  6. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  7. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
  8. History of or current brain metastases
  9. Psychiatric disorder that would preclude compliance
  10. 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)
  11. Subjects with reproductive potential not willing to use an effective method of contraception
  12. Lactating women
  13. Known dihydropyrimidine dehydrogenase deficiency
  14. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
  15. Major surgery within 4 weeks of start of study treatment, without complete recovery
  16. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515190

Contacts
Contact: Sook Ryun Park, M.D. +82-31-920-1609 sukryun73@ncc.re.kr
Contact: Se Youn Jang, M.S. +82-+31-920-0667 jj96smc@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: Se Youn Jang, M.S.    +82-31-920-0667    jj96smc@naver.com   
Sub-Investigator: Neo Kyenong Kim, M.D.Ph.D         
Sub-Investigator: Young Iee Park, M,D.Ph.D         
Sub-Investigator: Jong Seok Lee, M.D.         
Sub-Investigator: Byung-Ho Nam, M.D.Ph.D         
Sub-Investigator: Young-Ho Yun, M.D.         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sook Ryun Park, M.D. National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Sook Ryun Park, M.D., National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00515190     History of Changes
Other Study ID Numbers: NCCCTS-07-265, 82-31-920-1609
Study First Received: August 10, 2007
Last Updated: December 21, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Stomach Neoplasms
Secondary
Combination chemotherapy
S-1
oxaliplatin

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014