Back to resultsA Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Cisplatin
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring cholangiocarcinoma, gemcitabine, carboplatin, cisplatin
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
- Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL
- Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
- Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation
- Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
- ECOG status ≤ 1 at screening
Exclusion Criteria:
- Subjects will be eligible for the study if they meet all inclusion criteria
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Gemcitabine alone for 6 cycles
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Progression Free Survival
Full Information
NCT ID
NCT03081039
First Posted
February 9, 2017
Last Updated
February 15, 2018
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03081039
Brief Title
A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
Official Title
A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Competing study
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
April 28, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.
Detailed Description
Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
cholangiocarcinoma, gemcitabine, carboplatin, cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 1:1 to one of two treatment arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Gemcitabine alone for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Arm A: Given with either Cisplatin or Carboplatin every 21 days for 6 weeks. Dose based on individuals weight.
Arm B: Gemcitabine alone every 21 days for 6 cycles. Dose based on weight.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Every three months for 4 years
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Every three months for 4 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL
Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation
Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
ECOG status ≤ 1 at screening
Exclusion Criteria:
Subjects will be eligible for the study if they meet all inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martin, MD, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
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