Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01283204
First received: January 24, 2011
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This study is to evaluate the antitumor activity (i.e. progression free survival, overall survival, response rate, etc), safety and quality of life in patient with recurrent or metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents according to the results of pharmacogenetic study.


Condition Intervention Phase
Recurrent or Metastatic Gastric Cancer
Drug: SP
Drug: FL/Tax
Drug: FL/Doc
Drug: FOLFOX
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: Randomized Phase II Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • progression free survival(PFS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Imaging assessments will be performed every 6 weeks until radiographically documented PD(Progressive Disease).


Estimated Enrollment: 228
Study Start Date: February 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SP(S-1 with cisplatin)

SP <Every 3 weeks>

  1. Day 1~14 : TS-1 80mg/m2/day (PO)
  2. Day 1 : CDDP 60mg/m2/day IVF 2hours
  3. Day 15~21 : Rest
Drug: SP

<Every 3 weeks>

  1. Day 1~14 : TS-1 80mg/m2/day (PO),
  2. Day 1 : CDDP 60mg/m2/day IVF 2hours,
  3. Day 15~21 : Rest.
Other Name: TS-1® with Cisplatin
Active Comparator: FL/Tax(Paclitaxel with Leucovorin with 5-FU)

FL/Tax <Every q 3 weeks>

  1. Day1 : Paclitaxel 175mg/m2 IVF for 2hours
  2. Day1 : Leucovorin 20mg/m2 IVF for 1hour
  3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours
Drug: FL/Tax

<Every q 3 weeks>

  1. Day1 : Paclitaxel 175mg/m2 IVF for 2hours
  2. Day1 : Leucovorin 20mg/m2 IVF for 1hour
  3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours
Other Name: Paclitaxel with Leucovorin with 5-FU
Active Comparator: FL/Doc(Decetaxel with Leucovorin with 5-FU)

FL/Doc <Every q 3 weeks>

  1. Day1 : Docetaxel 75mg/m2 IVF for 1hour
  2. Day1 : Leucovorin 20mg/m2 IVF for 1hour
  3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours
Drug: FL/Doc

<Every q 3 weeks>

  1. Day1 : Docetaxel 75mg/m2 IVF for 1hour
  2. Day1 : Leucovorin 20mg/m2 IVF for 1hour
  3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours
Other Name: Docetaxel with Leucovorin with 5-FU
Active Comparator: FOLFOX(Oxaliplatin with Leucovorin with 5-FU)
FOLFOX <Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours
Drug: FOLFOX
<Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours
Other Name: Oxaliplatin with Leucovorin with 5-FU

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the stomach
  • Unresectable metastatic disease or recurred AGC
  • Age ≥ 20 years old
  • Eastern Cooperative Oncology Group performance status 0-2
  • Estimated life expectancy > 12weeks
  • Patients with pre-treatment(radiotherapy, chemotherapy) is not carried out. (However, adjuvant chemotherapy using one kind of medication is allowed. It must passed more than 6 months since end of the treatment.) Conventional radiation therapy should be performed before more than 2 weeks. And it is not allowed radiation therapy on primary tumor, measurable lesions, and abdominal
  • According to RECIST ver.1.1, using imaging techniques (CT or MRI), measurement possible disease or not measurable, but assessable disease
  • Screening laboratory values within the following limits : Hemoglobin ≥ 9 g/dL, Absolute neutrophil count ≥ 1.5 x 10³/L, Platelet count ≥ 75 x 10³/L, Serum creatinine ≤ 1.5 x UNL, Creatinine clearance ≥ 50 mL/min, AST/ALT ≤ 5.0 x UNL
  • The patient or protector have to sign a consent form. And he should be able to understand the right to withdraw consent without disadvantage.

Exclusion Criteria:

  • Prior chemotherapy (however, previous (neo-)adjuvant chemotherapy allowed if finished at least 6month ago except S-1, Paclitaxel, Docetaxel, Oxaliplatin . Allowed 5-FU, Cisplatin if finished 6month ago)
  • Patients with oral intake is impossible or with malabsorption syndrome
  • Patients with medically uncontrolled severe complications or infection
  • Patients who have central nervous system disorders, mental disorders, or evidence of CNS metastases
  • Patient with diagnosed active overlapping cancer within the past 5years except adequately treated carcinoma insitu of the cervix, basal or squamous cell carcinoma of skin
  • The possibility(will) of pregnancy , or pregnant and lactating women
  • Patients with clinically significant heart disease
  • Progression of gastric lesions is not possible to evaluate
  • During clinical trials, patient receiving of systemic chemotherapy or other clinical trials drugs or radiotherapy (However, it is possible that palliative radiotherapy treatment for pain relief on primary lesion after more than 2 weeks)
  • Peripheral neuropathy of Grade 2 or greater.
  • Patients who taking drugs to change of pharmacological activity of S-1 medicine(Warfarin, phenytoin, allopurinol etc.). Except regular treatment of corticosteroids(or equivalent drugs). However, it is allowed the purposes for pre-treatment of study drugs and the control of nausea and vomiting. (However, it is allowed the treatment for acute allergic reactions, or the treatment with low doses (methylprednisolone 20mg or less, or the equivalent drug) from about 6 months)
  • Other cases

    • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
    • Psychological condition or dementia that would not permit the subject to complete the study or sign informed consent
    • Patients with dropout sure in clinical trials or cannot be regular follow-up following reasons. For example, psychological, social, family, geographic reasons or a difficult condition of compliance with clinical trial and proper follow up.
    • Poorly controlled chronic liver disease or diabetes mellitus
    • Else, in the investigator's opinion, should exclude the patient from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283204

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sun-Young Rha, MD, Ph.D    82-2-2228-8050    rha7655@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01283204     History of Changes
Other Study ID Numbers: 4-2009-0596
Study First Received: January 24, 2011
Last Updated: February 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Docetaxel
Cisplatin
Fluorouracil
Paclitaxel
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on July 29, 2014