A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01297998|
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Drug: gemcitabine , cisplatin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||June 2013|
|Experimental: gemcitabine , cisplatin||
Drug: gemcitabine , cisplatin
Dose of gemcitabine and cisplatin and treatment schedule
Other Name: Gemcitabine;gemzer,Cisplatin;Cispulan
- Maximum tolerated dose [ Time Frame: Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1) ]To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
- Number of Participants with dose limiting toxicity [ Time Frame: At the end of adjuvant chemotherapy (6 months) ]
Dose limiting toxicity is defined as follows
- Grade 4 neutropenia, thrombocytopenia
- Grade 3 or 4 febrile neutropenia
- Grade 3 or 4 non-hematological adverse events unless unresponsive to treatment
- Any adverse events resulting in interruption of dosing on day 8 in both the two courses
- Any adverse events resulting in dose modification or delay of longer than 2 week
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297998
|Kobe University Graduate School of Medicine|
|Kobe, Japan, 650-0017|
|Study Director:||Tetsuo Ajiki, MD, PhD||Kobe University Graduate School of Medicine|