Salvage mFOLFOX in BTC After Failure of Gemcitabine

Unresectable Biliary Tract Cancer Clinical Trial

Official title:

Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127555
• Other study ID #: CAUHHO 2010-2
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: October 6, 2013
• Start date: April 2010
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: Chung-Ang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age : older than 18

2. Histologically confirmed adenocarcinoma of the biliary tract

3. Metastatic or unresectable biliary cancer

4. Prior exposure to gemcitabine chemotherapy for biliary cancer

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2

6. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT

7. Adequate bone marrow, liver, renal function

Exclusion Criteria:

1. Pregnancy and breast-feeding.

2. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).

3. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.

4. Symptomatic or uncontrolled brain metastasis

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Unresectable Biliary Tract Cancer

Intervention

Drug:
• 5-fluorouracil, leucovorin, oxaliplatin
D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Yongsan Hospital	Yongsan	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Chung-Ang University	Dong-A University Hospital, Gyeongsang National University Hospital, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan	1 year	No
Secondary	To evaluate the safety	Clinically assessed every cycle (2weeks)	1 year	No
Secondary	To estimate the time to progression		1 year	No
Secondary	To estimate overall survival		1 year	No