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Trial record 23 of 3324 for:    Louisville

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Recruitment Status : Withdrawn (Competing study)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

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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
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
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : April 28, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
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 B
Gemcitabine alone for 6 cycles
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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Every three months for 4 years ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Every three months for 4 years. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081039


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Robert Martin, MD, PhD University of Louisville

Responsible Party: Robert C. Martin, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT03081039     History of Changes
Other Study ID Numbers: UL 2016.1
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert C. Martin, University of Louisville:
cholangiocarcinoma
gemcitabine
carboplatin
cisplatin

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Carboplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs