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A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

Primary Purpose

Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine and Oxaliplatin
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Biliary Tract Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed biliary tract adenocarcinoma

  2. Inoperable disease as defined by:

    • Localized disease in a portion of the liver that does not allow the possibility of complete surgical removal of the tumor with a clear resection margin.

      • Presence of metastatic lesion

        • Unresectable recurrent tumor after curative resection

          • anatomically resectable but inoperable associated with medical condition
  3. Biliary obstruction controlled
  4. Minimum life expectancy of 12 weeks.
  5. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study
  6. Age over 18 years
  7. ECOG performance status of * 2.
  8. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤3xUNL; AST and/or ALT < 5x UNL; Creatinine< 1.5mg/dl or creatinine clearance >50 ml/mins
  9. Consent form signed and dated prior to study specific procedures.
  10. Subject able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion Criteria:

  1. Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
  2. Prior systemic chemotherapy
  3. Subject with reproductive potential (M/F) not using adequate contraceptive measures.
  4. Pregnancy and breast-feeding.
  5. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
  6. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
  7. Symptomatic or uncontrolled brain metastasis
  8. Other concomitant anticancer agent, including Tamoxifen and Interferon.
  9. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons.
  10. Participation in another clinical study or within 30 days before inclusion.
  11. History of severe hypersensitivity reactions to gemcitabine or oxaliplatin

Sites / Locations

  • Soonchunhyang University Bucheon Hospital

Outcomes

Primary Outcome Measures

1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma

Secondary Outcome Measures

1) To evaluate the safety and tolerability of the treatment combination. 2) To estimate the time to progression and the duration of overall response. 3) To estimate overall tumor growth control rate (CR, PR plus SD). 4) To estimate overall survival.

Full Information

First Posted
July 18, 2007
Last Updated
May 19, 2014
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00504192
Brief Title
A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Official Title
A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies. A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea.
Detailed Description
Treatment scheme :Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion Each cycle is repeated every 2 weeks. Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin, Combination Chemotherapy, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine and Oxaliplatin
Intervention Description
gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks
Primary Outcome Measure Information:
Title
1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma
Time Frame
every 4 cycles
Secondary Outcome Measure Information:
Title
1) To evaluate the safety and tolerability of the treatment combination. 2) To estimate the time to progression and the duration of overall response. 3) To estimate overall tumor growth control rate (CR, PR plus SD). 4) To estimate overall survival.
Time Frame
Overall survival is defined from the first day of treatment to the date of death. Time to progression is defined from the first day of treatment to the date of tumor progression assessed by CT scan or MRI.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically or cytologically confirmed biliary tract adenocarcinoma Inoperable disease as defined by: Localized disease in a portion of the liver that does not allow the possibility of complete surgical removal of the tumor with a clear resection margin. Presence of metastatic lesion Unresectable recurrent tumor after curative resection anatomically resectable but inoperable associated with medical condition Biliary obstruction controlled Minimum life expectancy of 12 weeks. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study Age over 18 years ECOG performance status of * 2. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤3xUNL; AST and/or ALT < 5x UNL; Creatinine< 1.5mg/dl or creatinine clearance >50 ml/mins Consent form signed and dated prior to study specific procedures. Subject able to comply with the scheduled follow-up and with the management of toxicities. Exclusion Criteria: Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification Prior systemic chemotherapy Subject with reproductive potential (M/F) not using adequate contraceptive measures. Pregnancy and breast-feeding. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics). Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. Symptomatic or uncontrolled brain metastasis Other concomitant anticancer agent, including Tamoxifen and Interferon. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons. Participation in another clinical study or within 30 days before inclusion. History of severe hypersensitivity reactions to gemcitabine or oxaliplatin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Sik Hong, professor
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
State/Province
Kyunggi
ZIP/Postal Code
420-767
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

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