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Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas
This study is currently recruiting participants.
Verified by Hoosier Oncology Group, October 2008
Sponsors and Collaborators: Hoosier Oncology Group
Sanofi-Aventis
OSI Pharmaceuticals
Information provided by: Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00532441
  Purpose

An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.


Condition Intervention Phase
Hepatocellular Carcinoma
Biliary Tract Carcinoma
Drug: Erlotinib
Drug: Docetaxel
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel Erlotinib Erlotinib hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:
  • To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the response rate, duration of response, disease control and overall survival. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To evaluate the safety and toxicity of erlotinib in combination with docetaxel. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • To correlate responses with biologic tumor markers. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Erlotinib
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Drug: Docetaxel
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Detailed Description:

Outline: This is a multi-center study.

Patients who meet eligibility criteria will receive treatment as follows until disease progression or excessive toxicities:

  • Erlotinib 150 mg p.o. daily on days 2-7, 9-14, 16-28
  • Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8, 15

Treatment cycle = 28 days

Performance Status: ECOG performance status 0 to 2

Life expectancy: At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count (ANC) > 1000 mm3
  • Platelet count > 75,000 mm3
  • Hemoglobin > 8 g/dL

Hepatic:

  • Bilirubin < 2.0 x upper limit of normal (ULN)
  • Transaminases (AST, ALT) < 5.0 x ULN if alkaline phosphatase is < 2.5 x ULN, or alkaline phosphatase < 5 x ULN if transaminases are < 1.5 x ULN.
  • If not on anticoagulation: PT < 4 seconds above ULN; INR < 1.5; PTT < 1.3 x ULN.
  • If on therapeutic anticoagulation, patients may have an INR > 1.5 and PTT within therapeutic range; INR will be monitored weekly until stable.
  • Serum Albumin > 3.0

Renal:

  • Creatinine clearance of > 60 ml/ min (by Cockcroft-Gault)

Pulmonary:

  • Not specified
  Eligibility

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

Inclusion Criteria:

  • Histological or cytological proof of hepatocellular or biliary tract carcinomas, not amenable to curative resection or transplantation.
  • Prior cancer treatment completed at least 30 days prior to being registered for protocol therapy and recovered from the acute toxicity effects of the regimen.
  • Patients may have had radiofrequency ablation, cryosurgery or embolization, but must have documented progressive disease with the involved lesion, or at least one previously untreated lesion.
  • Patients may have had ≤ 2 prior chemotherapy regimens.
  • Prior radiation therapy allowed to < 25% of the bone marrow at least 30 days prior to being registered for protocol therapy.
  • Patients with biliary obstruction must have percutaneous transhepatic drainage or endoscopic stent placement prior to starting study treatment.
  • Patients with a history of malignancy are eligible provided they have been curatively treated and demonstrate no evidence for recurrence of that cancer.
  • Peripheral neuropathy ≤ grade 1.
  • Patients must agree to abstain from frozen or fresh grapefruit or grapefruit juice for 5 days prior to, and during treatment.
  • Patients must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 12 week period thereafter.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age ≥ 18 years at time of consent.

Exclusion Criteria:

  • No previous treatment with EGFR inhibitors.
  • No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
  • No symptomatic brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
  • No Child-Pugh B or C liver cirrhosis.
  • No active corneal erosions or history of abnormal corneal sensitivity test.
  • No history of aneurysm or arteriovenous malformation.
  • No hemorrhage/bleeding event > CTCAE Grade 3 within 30 days prior to begin registered for protocol therapy.
  • No clinically significant infections as judged by the treating investigator.
  • No condition that impairs patient's ability to swallow whole pills.
  • No history of hypersensitivity to docetaxel or other drugs formulated with polysorbate 80.
  • Females must not be breastfeeding.
  • Patients who cannot avoid the following medications will be ineligible for the trial: midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, phenobarbital, phenytoin, carbamazepine, and rifampin (induction) and anti-retrovirals (including ritonavir, saquinavir).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532441

Contacts
Contact: Elena Gabriela Chiorean, M.D. 317-278-6942 gchiorea@iupui.edu
Contact: Jayme Harvey 317-921-2050 harveyj@iupui.edu

Locations
United States, Indiana
Indiana University Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Elena Gabriela Chiorean, M.D.     317-278-6942     gchiorea@iupui.edu    
Contact: Kerry Bridges     317-274-2552     kdbridge@iupui.edu    
Sponsors and Collaborators
Hoosier Oncology Group
Sanofi-Aventis
OSI Pharmaceuticals
Investigators
Study Chair: Elena Gabriela Chiorean, M.D. Hoosier Oncology Group, LLC
  More Information

Hoosier Oncology Group Home Page  This link exits the ClinicalTrials.gov site

Responsible Party: Hoosier Oncology Group ( Elena Gabriela Chiorean, M.D. )
Study ID Numbers: GI06-101
Study First Received: September 18, 2007
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00532441  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Erlotinib
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Carcinoma
Liver Neoplasms
Docetaxel
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009