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

NCT03081039 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: UL 2016.1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

cholangiocarcinoma; gemcitabine; carboplatin; cisplatin

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Every three months for 4 years

Secondary Outcomes (1)

• Progression Free Survival

  Every three months for 4 years.

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Cisplatin or Carboplatin with Gemcitabine for 6 cycles

Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine

Arm B

ACTIVE COMPARATOR

Gemcitabine alone for 6 cycles

Drug: Gemcitabine

Interventions

Carboplatin DRUG

Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.

Arm A

Cisplatin DRUG

Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.

Arm A

Gemcitabine DRUG

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.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Carboplatin; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert Martin, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be randomized 1:1 to one of two treatment arms.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: March 15, 2017
• Study Start: August 21, 2017
• Primary Completion: April 28, 2022
• Study Completion: December 31, 2022
• Last Updated: February 19, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)