Gemcitabine + Oxaliplatin +Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer
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|ClinicalTrials.gov Identifier: NCT03943043|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
The objective of the study is to determine a new combination of drug that improves the outcome in patients with advanced (unresectable or metastatic) BTC. The primary objective of the phase I part of the study is to determine the maximum tolerated dose (MTD) of the combination gemcitabine plus oxaliplatin plus nab-paclitaxel, established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D).
The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel. The secondary objectives of the study consist in to better define the safety profile and the outcome of the study treated population.
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: nab-paclitaxel||Phase 1 Phase 2|
Systemic chemotherapy is increasingly being applied in cases of biliary tract cancers. A benefit for chemotherapy over best supportive care alone was suggested in a trial that randomly assigned 90 patients with advanced pancreatic or biliary cancer (37 with bile duct cancer) to fluorouracil (FU)-based systemic chemotherapy or best supportive care alone (median survival 6 versus 2.5 months, respectively) (1).
The literature regarding treatment results with specific regimens is limited because most series are small, and many reports consist of a mix of bile duct cancers, gallbladder cancer, ampullary cancer, and either pancreatic or hepatocellular cancers. Although they arise in similar locations, these cancers all have a unique natural history and response to chemotherapy. In general, no single drug or combination has consistently increased median survival beyond the expected six to eight months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Phase I-II Trial of Gemcitabine Plus Oxaliplatin and Nab-paclitaxel in Subjects With Advanced (Unresectable or Metastatic) Biliary Tract Cancer|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: gemcitabine oxaliplatin nab-paclitaxel
combination at different dose of gemcitabine, oxaliplatin and nab-paclitaxel
Phase I dosing regimens:
The dose of treatment will be assigned at the time of enrolment in one of these 3 subsequent dose-levels:
- 1° level: gemcitabine 800 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 80 mg/m2 0° level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 100 mg/m2
Gemcitabine plus oxaliplatin plus nab-paclitaxel according to RP2D.
- maximum tolerated dose [ Time Frame: 4 weeks ]Determination of the maximum tolerated dose for phase I
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 16 weeks ]The secondary objectives of the study consist in to better define the safety profile as assessed by CTCAE V4.0
- Number of responder (in term of CR, PR, SD) to GEMOX plus nab-paclitaxel as assessed by RECIST 1.1 [ Time Frame: Maximum of 24 weeks ]Determination of activity of GEMOX plus nab-paclitaxel as assessed by RECIST 1.1
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): NCT03943043
|Contact: Armando Santoro, MD||02 email@example.com|
|Contact: Tiziana Pressiani, MD||02 firstname.lastname@example.org|
|Istituto Clinico Humanitas||Recruiting|
|Rozzano, Milan, Italy, 20089|
|Contact: Armando Santoro, MD 02 82244080 email@example.com|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|