CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01766219
First received: January 10, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with advanced or metastatic cholangiocarcinoma that cannot be removed by surgery. 6,8-Bis(benzylthio)octanoic acid may stop the growth of cholangiocarcinoma by blocking blood flow to the tumor


Condition Intervention
Adult Primary Cholangiocellular Carcinoma
Advanced Adult Primary Liver Cancer
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Localized Unresectable Adult Primary Liver Cancer
Metastatic Extrahepatic Bile Duct Cancer
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Unresectable Extrahepatic Bile Duct Cancer
Drug: 6,8-bis(benzylthio)octanoic acid

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Open-Label Clinical Trial of CPI-613 in Patients With Advanced Bile Duct Cancers

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 3 years ] [ Designated as safety issue: No ]
    Estimated using Kaplan-Meier techniques.


Secondary Outcome Measures:
  • Response rate defined as proportion of patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), using based on the RECIST version 1.1 [ Time Frame: From the start of the treatment until DP, assessed up to 3 year ] [ Designated as safety issue: No ]
    95% confidence interval will be included.

  • Progression-free survival [ Time Frame: From the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression (DP) or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    Estimated using Kaplan-Meier techniques.

  • Adverse events, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 [ Time Frame: Up to 1 month after completion of study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 13
Study Start Date: May 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (6,8-bis[benzylthio]octanoic acid)

Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.

Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.

Drug: 6,8-bis(benzylthio)octanoic acid
Given IV
Other Names:
  • alpha-lipoic acid analogue CPI-613
  • CPI-613

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the safety and efficacy of CPI-613 (6,8-bis[benzylthio]octanoic acid) in patients with advanced unresectable cholangiocarcinoma who have failed available therapies.

OUTLINE:

Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-5, 1 week prior to course 1.

Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.

After completion of study treatment, patients are followed up bimonthly.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically and cytologically proven cholangiocarcinoma of any type (including intrahepatic cholangiocarcinoma, extrahepatic primary cholangiocarcinoma, hilar cholangiocarcinomas, cholangiocarcinomas located in the gall bladder or hepatic capsule effraction, and carcinoma of the Ampulla of Vater, etc.) that is not amenable to surgery, radiation, or combined modality therapy with curative intent, and has failed or is not eligible for available chemotherapies such as gemcitabine with or without platinum
  • Local, locally-advanced, or metastatic disease documented as having shown progression on a scan (e.g., computed tomography [CT], magnetic resonance imaging [MRI])
  • Measurable tumor according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with at least one unidimensionally measurable target lesion
  • No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below 1.5 x upper level of normal (ULN)
  • No acute toxic effects from previous treatment superior to grade 1 at the start of the study
  • Eastern Cooperative Oncology Group (ECOG) performance status being 0-3
  • Expected survival > 3 months
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
  • Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists
  • Granulocyte count >= 1500/mm^3
  • White blood cell (WBC) >= 3500 cells/mm^3 or >= 3.5 bil/L
  • Platelet count >=100,000 cells/mm^3 or >=100 bil/L
  • Absolute neutrophil count (ANC) >=1500 cells/mm^3 or >=1.5 bil/L
  • Hemoglobin >= 9 g/dL or >= 90 g/L
  • Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper normal limit (UNL), alanine aminotransferase (ALT/serum glutamate pyruvate transaminase [SGPT]) =< 3 x UNL (=< 5 x UNL if liver metastases present)
  • Bilirubin =< 1.5 x UNL
  • Serum creatinine =< 2.0 mg/dL or 177 µmol/L
  • International normalized ratio or INR must be =< 1.5
  • No evidence of active infection and no serious infection within the past month
  • Mentally competent, ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment
  • Serious medical illness that would potentially increase patients' risk for toxicity
  • Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
  • Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown)
  • Lactating females
  • Fertile men unwilling to practice contraceptive methods during the study period
  • Life expectancy less than 3 months
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
  • Unwilling or unable to follow protocol requirements
  • Dyspnea with moderate exertion; patients with clinically significant pleural or pericardial effusions
  • Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure; also patients with a history of myocardial infarction that is < 1 year prior to registration, or patients with previous congestive heart failure (< 1 year prior to registration) requiring pharmacologic support or with left ventricular ejection fraction < 50%)
  • A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
  • Evidence of active infection, or serious infection within the past month
  • Patients with known human immunodeficiency virus (HIV) infection
  • Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
  • Requirement for immediate palliative treatment of any kind including surgery
  • Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
  • Prior illicit drug addiction
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766219

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Amy Neal, RN    336-713-6912    aneal@wakehealth.edu   
Principal Investigator: Angela T. Alistar         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Angela Alistar Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01766219     History of Changes
Other Study ID Numbers: CCCWFU 59212, NCI-2013-00063, P30CA012197
Study First Received: January 10, 2013
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board
United States : Food and Drug Adminstration

Additional relevant MeSH terms:
Cholangiocarcinoma
Carcinoma
Liver Neoplasms
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 01, 2014