A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group
ClinicalTrials.gov Identifier:
NCT01297998
First received: February 7, 2011
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.


Condition Intervention Phase
Biliary Tract Cancer
Drug: gemcitabine , cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy

Resource links provided by NLM:


Further study details as provided by Kansai Hepatobiliary Oncology Group:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1) ] [ Designated as safety issue: Yes ]
    To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy


Secondary Outcome Measures:
  • Number of Participants with dose limiting toxicity [ Time Frame: At the end of adjuvant chemotherapy (6 months) ] [ Designated as safety issue: Yes ]

    Dose limiting toxicity is defined as follows

    1. Grade 4 neutropenia, thrombocytopenia
    2. Grade 3 or 4 febrile neutropenia
    3. Grade 3 or 4 non-hematological adverse events unless unresponsive to treatment
    4. Any adverse events resulting in interruption of dosing on day 8 in both the two courses
    5. Any adverse events resulting in dose modification or delay of longer than 2 week


Enrollment: 24
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gemcitabine , cisplatin Drug: gemcitabine , cisplatin
Dose of gemcitabine and cisplatin and treatment schedule
Other Name: Gemcitabine;gemzer,Cisplatin;Cispulan

Detailed Description:

Surgery currently remains the only potentially curative treatment for biliary tract cancer (BTC), and most patients develop recurrence. Therefore, effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients. However, to date, no standard adjuvant chemotherapy has been established, and a guideline for BTC treatment recommends that trials of adjuvant chemotherapy be carried out.

Based on results from clinical studies in unresectable BTC, gemcitabine, platinum agent, fluoropyrimidine are considered to have activity against BTC. These agents are expected to be effective in the postoperative adjuvant therapy for BTC, Thus, randomized controlled trials with gemcitabine are ongoing, and the results are expected. Recently, in the ABC-02 study, the first prospective multicenter phase III study in patients with unresectable BTC, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST (from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for unresectable BTC, and we expect this regimen to be effective for postoperative adjuvant therapy.

Though hepatectomy is frequently performed in surgery for BTC, it is unclear that the effect of anticancer agent is affected by hepatectomy. Because gemcitabine is metabolized by cytidine deaminase primarily in the liver, it considered to have decreased the metabolic ability of gemcitabine after hepatectomy. Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine. In the adjuvant chemotherapy with gemcitabine, it is necessary to examine separately whether hepatectomy was undergone or not.

In this study, we aimed to assess the safety and efficacy of gemcitabine/cisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biliary tract cancer (BTC) with more than stage IB
  2. BTC undergoing R0 or R1 resection without major hepatectomy
  3. Older than 20 years old
  4. PS0 or 1
  5. No treatment other than surgery
  6. No dysfunction of main organs
  7. Possible oral intake
  8. Treatment start; after 4 weeks and within 12 weeks after surgery
  9. Obtained written informed consent

Exclusion Criteria:

  1. Patients with resection of major hepatectomy
  2. Patients with double cancers
  3. Patients having severe allergy
  4. Patients with severe organ dysfunction
  5. Patients with active infectious disease
  6. Pregnancy
  7. Patients with severe psychological disease
  8. Patients seem inadequate for this study by investigators
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01297998

Locations
Japan
Kobe University Graduate School of Medicine
Kobe, Japan, 650-0017
Sponsors and Collaborators
Kansai Hepatobiliary Oncology Group
Investigators
Study Director: Tetsuo Ajiki, MD, PhD Kobe University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Kansai Hepatobiliary Oncology Group
ClinicalTrials.gov Identifier: NCT01297998     History of Changes
Other Study ID Numbers: KHBO1004, UMIN000004622
Study First Received: February 7, 2011
Last Updated: June 29, 2014
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014