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Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234051
Recruitment Status : Unknown
Verified November 2010 by Korean South West Oncology Group.
Recruitment status was:  Recruiting
First Posted : November 4, 2010
Last Update Posted : December 12, 2011
Information provided by (Responsible Party):
Korean South West Oncology Group

Brief Summary:
  1. Goals

    • The primary goal of this phase II trial is to:

    evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy

    Secondary goals are to:evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population

  2. Design

The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon.22

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Docetaxel, Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Study Start Date : November 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Docetaxel, oxaliplatin, palliative chemotherapy Drug: Docetaxel, Oxaliplatin

1. Treatment Schedule

1.1. Docetaxel schedule Docetaxel 35 mg/m2 is administered on day 1 and day 8 by intravenously in 100 mL of 5% dextrose solution over 30 minutes. Dexamethasone 8mg is intravenously administered before 30 minutes, and then orally 4mg every 12 hours over 48 hours. In the event of a hypersensitivity reaction, dimethidine maleate, epinephrine, and intravenous fluids will be required.

1.2. Oxaliplatin schedule Oxaliplatin 100 mg/m2 is given on day 1 by intravenous infusion in 500 mL of 5% dextrose solution over 120 minutes. Therapy will be repeated every 21 days.

Primary Outcome Measures :
  1. Response rate [ Time Frame: 2years ]

Secondary Outcome Measures :
  1. Treatment-related toxicities [ Time Frame: 2 years ]
    Number and proportion of patients with adverse events according to the NCI-CTCAE (v 4.0) as a measure of treatment-related toxicities

  2. Progression free survival [ Time Frame: 2 years ]

    Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves.

    The median PFS and OS will be used for measure.

  3. Overall survival [ Time Frame: 2 years ]

    Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves.

    The median PFS and OS will be used for measure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who were diagnosed as adenocarcinoma of gallbladder or biliary tract histologically or cytologically
  2. Unresectable locally advanced, metastatic, or recurrent biliary tract cancer
  3. Patients must be ≥ 18 years old of age
  4. ECOG performance status ≤ 2 (see Appendix C)
  5. At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (see Appendix D)
  6. Estimated life expectancy of more than 3 months
  7. Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)
  8. Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
  9. Adequate liver function (serum total bilirubin < 3xULN; serum transaminases levels < 5xUNL)
  10. Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

  1. Other tumor type than adenocarcinoma
  2. Any previous history of chemotherapy for biliary tract cancer (prior neoadjuvant/adjuvant chemotherapy is allowed, if recurrence occurred more than 6 months after completion of previous chemotherapy)
  3. Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
  4. Patients who received radiotherapy on target lesion within 6 months prior to study treatment
  5. Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
  6. Patients who received major surgery within 4 weeks of starting study treatment or was not recovered from any effects of major surgery
  7. Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
  8. Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
  9. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01234051

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Contact: Eun Ki Song +82-63-250-1245
Contact: Hwan Jung Yun +82-42-280-7157

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Korea, Republic of
Eun Ki Song Recruiting
Chonbuk, Korea, Republic of
Contact: Eun Ki Song   
Contact: Hwan Jung Yun   
Sponsors and Collaborators
Korean South West Oncology Group
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Principal Investigator: Eun Ki Song Chonbuk National Universitiy Hospital

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Responsible Party: Korean South West Oncology Group Identifier: NCT01234051     History of Changes
Other Study ID Numbers: KSWOG 2010-1
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: November 2010
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action