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

This study has been completed.
Sponsor:
Information provided by:
Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT00504192
First received: July 18, 2007
Last updated: May 19, 2014
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Advanced Biliary Tract Adenocarcinoma
Gemcitabine
Oxaliplatin
Combination Chemotherapy
Efficacy
Drug: Gemcitabine and Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ 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. ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: September 2006
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine and Oxaliplatin
    gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504192

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Kyunggi, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Dae Sik Hong, professor Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Dae Sik Hong, Soonchunhyang Bucheon Hospital
ClinicalTrials.gov Identifier: NCT00504192     History of Changes
Other Study ID Numbers: SCH-GO-BTC1
Study First Received: July 18, 2007
Last Updated: May 19, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Biliary Tract Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014