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

Phase 3

Withdrawn

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin

• Registration Number: NCT03081039
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2017-02-09
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Study Start: 2017-08-21
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19
• Primary Completion: 2022-04-28
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Gemcitabine	Gemcitabine alone for 6 cycles
Arm A	Gemcitabine	Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Arm A	Carboplatin	Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Arm A	Cisplatin	Cisplatin or Carboplatin with Gemcitabine for 6 cycles

Primary Outcome Measures

Name	Time	Method
Overall Survival	Every three months for 4 years

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Every three months for 4 years.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States