NCT03943043

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3.1 years

First QC Date

April 9, 2018

Last Update Submit

July 28, 2020

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • maximum tolerated dose

    Determination of the maximum tolerated dose for phase I

    4 weeks

Secondary Outcomes (2)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    16 weeks

  • Number of responder (in term of CR, PR, SD) to GEMOX plus nab-paclitaxel as assessed by RECIST 1.1

    Maximum of 24 weeks

Study Arms (1)

gemcitabine oxaliplatin nab-paclitaxel

EXPERIMENTAL

combination at different dose of gemcitabine, oxaliplatin and nab-paclitaxel

Drug: nab-paclitaxel

Interventions

nab-paclitaxelDRUG

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
gemcitabine oxaliplatin nab-paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written, signed informed consent
  • Male or female aged 18 years or older
  • Histologically or citologically-confirmed advanced (unresectable or metastatic) BTC (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
  • Measurable or evaluable but non-measurable disease according to RECIST v. 1.1
  • Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 6 months before the trial entry is accepted)
  • Adequate bone marrow, liver, and renal function
  • ECOG PS 0-1
  • Life expectancy of at least 12 weeks
  • Negative serum pregnancy test for women of childbearing potential;
  • Adoption of adequate contraceptive methods when applicable Women of child-bearing potential must use the following adequate contraceptive methods during all the study and for 1 month after completion of study treatment: abstinence, tubal ligation, oral contraception or transdermal contraceptives, copper intrauterine device, vasectomy of the partner. For male patients with female partners of childbearing potential, agreement to use a barrier method of contraception from the first dose of treatment and for 6 months after completion of study treatment.
  • Male patients mustn't donate sperm during the treatment with nab-paclitexel and for 6 months after completion of study treatment.
  • Agreement not to donate blood during the study.

You may not qualify if:

  • Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as moderate symptoms; limiting instrumental activities of daily living (ADLs)
  • Previous systemic treatment for advanced disease
  • Known symptomatic brain metastases or carcinomatous meningitis
  • Severe or uncontrolled systemic disease and/or active or uncontrolled infection
  • Women who are currently pregnant or breast feeding
  • Previous or current malignancies of other histologies within the last 3 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
  • Known hypersensitivity to nab-paclitaxel, gemcitabine, oxaliplatin or any of the excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (1)

  • Pressiani T, Balsano R, Giordano L, Milella M, Bergamo F, Bozzarelli S, Noventa S, Ferrrari D, Scartozzi M, Parra HS, Auriemma A, Solda C, Zaniboni A, Zecchetto C, Rizzato MD, Rimassa L, Santoro A. Multicenter phase I/II trial of gemcitabine, oxaliplatin and nab-paclitaxel as first-line treatment for patients with advanced biliary tract cancer. Eur J Cancer. 2024 Aug;207:114196. doi: 10.1016/j.ejca.2024.114196. Epub 2024 Jun 29.

    PMID: 38954899DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

130-nm albumin-bound paclitaxelGemcitabineOxaliplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Armando Santoro, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Santoro, MD

CONTACT

02 82244080armando.santoro@cancercenter.humanitas.it

Tiziana Pressiani, MD

CONTACT

02 82244773tiziana.pressiani@humanitas.it

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 9, 2019

Study Start

July 21, 2017

Primary Completion

September 1, 2020

Study Completion

May 1, 2021

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)