A Phase 1/2 interventional study of nab-paclitaxel in Cholangiocarcinoma, sponsored by Istituto Clinico Humanitas. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Istituto Clinico Humanitas · Phase 1/2, Interventional, and Treatment
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.
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 85 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
combination at different dose of gemcitabine, oxaliplatin and nab-paclitaxel
Drug: 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 1. level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 125 mg/m2 2. level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 150 mg/m2 each administered on day 1, every 14 day Phase II: Gemcitabine plus oxaliplatin plus nab-paclitaxel according to RP2D.
Also known as: Gemcitabine, Oxaliplatin
maximum tolerated dose
Determination of the maximum tolerated dose for phase I
Time frame: 4 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The secondary objectives of the study consist in to better define the safety profile as assessed by CTCAE V4.0
Time frame: 16 weeks
Number of responder (in term of CR, PR, SD) to GEMOX plus nab-paclitaxel as assessed by RECIST 1.1
Determination of activity of GEMOX plus nab-paclitaxel as assessed by RECIST 1.1
Time frame: Maximum of 24 weeks
Plan to share: No
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas