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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

Phase 2
18 Years
Open (Enrolling)
Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin, Combination Chemotherapy, Efficacy

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Trial Information

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

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

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

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

- Presence of metastatic lesion

- Unresectable recurrent tumor after curative resection

- anatomically resectable but inoperable associated with medical

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

Exclusion Criteria:

1. Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Dae Sik Hong, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Soonchunhyang University Bucheon Hospital


South Korea: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Advanced Biliary Tract Adenocarcinoma
  • Gemcitabine
  • Oxaliplatin
  • Combination Chemotherapy
  • Efficacy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Biliary Tract Neoplasms