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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Korean South West Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Korean South West Oncology Group
ClinicalTrials.gov Identifier:
NCT01234051
First received: October 28, 2010
Last updated: December 9, 2011
Last verified: November 2010
  Purpose
  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 Intervention Phase
Biliary Tract Cancer
Drug: Docetaxel, Oxaliplatin
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: Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Resource links provided by NLM:


Further study details as provided by Korean South West Oncology Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2years ] [ Designated as safety issue: No ]

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

  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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.


  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 53
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01234051

Contacts
Contact: Eun Ki Song +82-63-250-1245 eksong@jbnu.ac.kr
Contact: Hwan Jung Yun +82-42-280-7157 hjyun@cnu.ac.kr

Locations
Korea, Republic of
Eun Ki Song Recruiting
Chonbuk, Korea, Republic of
Contact: Eun Ki Song       eksong@jbnu.ac.kr   
Contact: Hwan Jung Yun       hjyun@cnu.ac.kr   
Sponsors and Collaborators
Korean South West Oncology Group
Investigators
Principal Investigator: Eun Ki Song Chonbuk National Universitiy Hospital
  More Information

No publications provided

Responsible Party: Korean South West Oncology Group
ClinicalTrials.gov Identifier: NCT01234051     History of Changes
Other Study ID Numbers: KSWOG 2010-1
Study First Received: October 28, 2010
Last Updated: December 9, 2011
Health Authority: Republic of Korea: Korea Food and Drug Administration

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Docetaxel
Oxaliplatin
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014