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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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ClinicalTrials.gov Identifier: NCT03081039
Recruitment Status : Withdrawn (Competing study)
First Posted : March 15, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

February 9, 2017
March 15, 2017
February 19, 2018
August 21, 2017
April 28, 2022   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Every three months for 4 years ]
Same as current
Complete list of historical versions of study NCT03081039 on ClinicalTrials.gov Archive Site
Progression Free Survival [ Time Frame: Every three months for 4 years. ]
Same as current
Not Provided
Not Provided
 
A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
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
Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized 1:1 to one of two treatment arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Intrahepatic Cholangiocarcinoma
  • Drug: Carboplatin
    Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.
  • Drug: Cisplatin
    Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.
  • Drug: 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.

  • Active Comparator: Arm A
    Cisplatin or Carboplatin with Gemcitabine for 6 cycles
    Interventions:
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Active Comparator: Arm B
    Gemcitabine alone for 6 cycles
    Intervention: Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
48
December 31, 2022
April 28, 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03081039
UL 2016.1
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Robert C. Martin, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Robert Martin, MD, PhD University of Louisville
University of Louisville
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP