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

Brief Title

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

Official Title

Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

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
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Response rate

Secondary Outcome

 Treatment-related toxicities

Condition

Biliary Tract Cancer

Intervention

Docetaxel, Oxaliplatin

Study Arms / Comparison Groups

 Docetaxel, oxaliplatin, palliative chemotherapy

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

53

Start Date

November 2010

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eun Ki Song, +82-63-250-1245, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT01234051

Organization ID

KSWOG 2010-1

Responsible Party

Sponsor

Study Sponsor

Korean South West Oncology Group

Study Sponsor

Eun Ki Song, Principal Investigator, Chonbuk National Universitiy Hospital

Verification Date

November 2010