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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma

Conditions
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Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin, Combination Chemotherapy, Efficacy

Intervention / Treatment
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* Drug: Gemcitabine and Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine and Oxaliplatin|gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma |  | every 4 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |