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

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 3

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03081039

UL 2016.1

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Cisplatin or Carboplatin with Gemcitabine for 6 cycles

Treatment:

Drug: Gemcitabine

Drug: Carboplatin

Drug: Cisplatin

Arm B

Active Comparator group

Description:

Gemcitabine alone for 6 cycles

Treatment:

Drug: Gemcitabine