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

NCT00504192 | Completed Phase 2 DMC

• 1 other identifier: SCH-GO-BTC1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Biliary Tract Adenocarcinoma; Gemcitabine; Oxaliplatin; Combination Chemotherapy; Efficacy

Outcome Measures

Primary Outcomes (1)

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

  every 4 cycles

Secondary Outcomes (1)

• 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.

Interventions

Gemcitabine and Oxaliplatin DRUG

gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of severe hypersensitivity reactions to gemcitabine or oxaliplatin

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Kyunggi, 420-767, South Korea

Location

MeSH Terms

Interventions

Gemcitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Dae Sik Hong, professor

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 19, 2007
• Study Start: September 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: May 20, 2014

Record last verified: 2009-05

Locations

KR (1)