search
Back to results

Gemcitabine + Oxaliplatin +Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer

Primary Purpose

Cholangiocarcinoma

Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
nab-paclitaxel
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Istituto Clinico HumanitasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gemcitabine oxaliplatin nab-paclitaxel

Arm Description

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

Outcomes

Primary Outcome Measures

maximum tolerated dose
Determination of the maximum tolerated dose for phase I

Secondary Outcome Measures

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
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

Full Information

First Posted
April 9, 2018
Last Updated
July 28, 2020
Sponsor
Istituto Clinico Humanitas
search

1. Study Identification

Unique Protocol Identification Number
NCT03943043
Brief Title
Gemcitabine + Oxaliplatin +Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine oxaliplatin nab-paclitaxel
Arm Type
Experimental
Arm Description
combination at different dose of gemcitabine, oxaliplatin and nab-paclitaxel
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Gemcitabine, Oxaliplatin
Intervention Description
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 level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 125 mg/m2 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.
Primary Outcome Measure Information:
Title
maximum tolerated dose
Description
Determination of the maximum tolerated dose for phase I
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
The secondary objectives of the study consist in to better define the safety profile as assessed by CTCAE V4.0
Time Frame
16 weeks
Title
Number of responder (in term of CR, PR, SD) to GEMOX plus nab-paclitaxel as assessed by RECIST 1.1
Description
Determination of activity of GEMOX plus nab-paclitaxel as assessed by RECIST 1.1
Time Frame
Maximum of 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armando Santoro, MD
Phone
02 82244080
Email
armando.santoro@cancercenter.humanitas.it
First Name & Middle Initial & Last Name or Official Title & Degree
Tiziana Pressiani, MD
Phone
02 82244773
Email
tiziana.pressiani@humanitas.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Phone
02 82244080
Email
armando.santoro@humanitas.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gemcitabine + Oxaliplatin +Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer

We'll reach out to this number within 24 hrs