Phase II Trial of Oxaliplatin in Combination With S-1(SOX) in Patients With Recurrent or Metastatic Breast Cancer (TORCH)

This study has been completed.
Sponsor:
Collaborators:
Korean Cancer Study Group
National Cancer Center, Korea
Seoul National University Bundang Hospital
Samsung Medical Center
Asan Medical Center
Severance Hospital
Information provided by (Responsible Party):
Seock-Ah Im, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00527930
First received: September 8, 2007
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

Phase II trial of oxaliplatin in combination with S-1(SOX) in patients with recurrent or metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline and taxane


Condition Intervention Phase
Breast Neoplasms
Drug: TS-1 and Eloxatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Oxaliplatin in Combination With S-1(SOX) in Patients With Recurrent or Metastatic Breast Cancer (MBC) Previously Treated With or Resistant to an Anthracycline and Taxane

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: TTP, OS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - To determine the time to progression - To determine the response duration - To determine the overall survival - To determine toxicities - To determine the pharmacogenomic predictor (association study) [ Time Frame: PFS, OS ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: September 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: TS-1 and Eloxatin

    S-1 80 mg/m2/day on day 1-14 Oxaliplatin 130 mg/m2 IV for 2 hour on day 1 Every 3 week

    Number of Cycles: until progression or unacceptable toxicity

Detailed Description:

The main purpose of this study is to find out the efficacy and safety profile of TS-1 with oxaliplatin in previously anthracycline and taxane pretreated patients.

  Eligibility

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

Inclusion Criteria:

  • M/F age ≥ 18
  • Metastatic(TxNxM1) or inoperable locally recurrent breast cancer(rT4NxM0) after taxane & anthracycline therapy
  • Measurable disease (RECIST) : A patient with at least one measurable lesion of which the diameter is confirmed to be 10mm in spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT
  • No prior treatment with S-1, capecitabine, platinum In metastatic setting
  • Must have received an anthracycline and taxane in adj. or metastatic settings (concurrent, sequential, or combined with other drugs)
  • For taxanes (Paclitaxel (P) / Docetaxel (D))

    1. Must have progressed while or after receiving P or D (Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease)
    2. Only 1 adjuvant regimen permitted (neoadjuvant immediately followed by surgery and immediately followed by adj. is permitted)
  • For anthracyclines

    1. Progressed while on anthracycline treatment, with or without initial response or
    2. Have received an adequate course of anthracyclines defined as follows:
    1. Adj.: Must have received a standard regimen (doxorubicin ≥ 240 mg/m2 or ≥ 360 mg/m2 epirubicin or equivalent)
    2. Metastatic: Must have received a standard regimen(doxorubicin ≥300mg/m2 or equivalent)
  • Not candidate for Herceptin
  • ECOG PS ≤ 2
  • Completion of all prior chemotherapy ≥ 3 wks prior to enrol
  • Completion of hormonal therapy 2 wks prior to enroll
  • Resolution of all clinically significant toxic effects (excluding alopecia and sensory neuropathies) of any prior surgery or therapy to grade ≤ 1 (NCI CTCAE 3.0), for peripheral neuropathy grade ≤ 2 (NCI CTCAE 3.0), or to within the limits listed in the specific inclusion/exclusion criteria
  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
  • Informed consent obtained.

Exclusion Criteria:

  • WOCBP(woman of child bearing potential) unwilling to use acceptable method to avoid pregnancy
  • Breast feeding or pregnant women
  • Patients with Hx of symptomatic brain or leptomeningeal involvement (eligible if asymptomatic 2weeks after proper radiation therapy)
  • ≥grade 3 neuropathy currently
  • Hx of second malignancy except adequately treated basal or squamous skin ca or CIS of cervix. Adequately treated contralateral breast ca with DF >5 yrs prior to this study is permitted
  • MI, unstable angina, CABG, clinically significant arrhythmia within 6 mo
  • Hx of inflammatory bowel disease or chronic diarrhea,
  • ANC < 1500, Plt < 100K, Hb <9.0
  • Ccr < 60 ml/min or creatinine >1.5
  • Bil > 1.5 x UNL, AST/ALT ≥ 2.5xUNL if hepatic meta + > 5xUNL)
  • History of hypersensitivity to 5-FU, platinum, or to compounds with similar chemical structures
  • More than 3 prior chemotherapy for metastatic or recurrent disease or prior treatment with S-1, capecitabine or any platinum analogs in metastatic setting (5-FU combine with other agent in metastatic setting is allowed_ ex) CMF, FAC)
  • Her2(+) pts who are candidates for Herceptin
  • prior surgery within 4 week
  • participate in other clinical trials within 4 week
  • prior radiation therapy within 2 week
  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: NCT00527930

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Korean Cancer Study Group
National Cancer Center, Korea
Seoul National University Bundang Hospital
Samsung Medical Center
Asan Medical Center
Severance Hospital
Investigators
Principal Investigator: Seock-Ah Im, MD, PhD Seoul National University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Seock-Ah Im, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00527930     History of Changes
Other Study ID Numbers: KCSG-BR-0703, H-0706-009-209
Study First Received: September 8, 2007
Last Updated: October 9, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Breast Neoplasms
Oxaliplatin
S1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014