A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03081039
• Other study ID #: UL 2016.1
• Status: Withdrawn
• Phase: Phase 3
• First received: February 9, 2017
• Last updated: February 15, 2018
• Start date: August 21, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Carboplatin
Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.
• Cisplatin
Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.
• Gemcitabine
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.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Every three months for 4 years
Secondary	Progression Free Survival		Every three months for 4 years.