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
Overview
- Phase
- Phase 3
- Intervention
- Carboplatin
- Conditions
- Intrahepatic Cholangiocarcinoma
- Sponsor
- University of Louisville
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Robert C. Martin
Principal Investigator
University of Louisville
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
Arms & Interventions
Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Intervention: Carboplatin
Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Intervention: Cisplatin
Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
Intervention: Gemcitabine
Arm B
Gemcitabine alone for 6 cycles
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Every three months for 4 years
Secondary Outcomes
- Progression Free Survival(Every three months for 4 years.)