NCT00532441

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

February 12, 2016

Completed
Last Updated

February 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.9 years

First QC Date

September 18, 2007

Results QC Date

December 10, 2015

Last Update Submit

January 14, 2016

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 16 Weeks Progression-free Survival

    To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.

    Start of treatment until disease progression per RECIST criteria up to 16 weeks

Secondary Outcomes (2)

  • Response Rate

    18 months

  • Overall Survival

    18 Months

Study Arms (2)

Erlotinib and Docetaxel: Biliary

EXPERIMENTAL

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

Drug: ErlotinibDrug: Docetaxel

Erlotinib and Docetaxel: Hepatocellular

EXPERIMENTAL

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

Drug: ErlotinibDrug: Docetaxel

Interventions

ErlotinibDRUG

Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28

Erlotinib and Docetaxel: BiliaryErlotinib and Docetaxel: Hepatocellular
DocetaxelDRUG

Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Erlotinib and Docetaxel: BiliaryErlotinib and Docetaxel: Hepatocellular

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

IN Onc/Hem Associates

Indianapolis, Indiana, 46202, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Related Publications (1)

  • Chiorean EG, Ramasubbaiah R, Yu M, Picus J, Bufill JA, Tong Y, Coleman N, Johnston EL, Currie C, Loehrer PJ. Phase II trial of erlotinib and docetaxel in advanced and refractory hepatocellular and biliary cancers: Hoosier Oncology Group GI06-101. Oncologist. 2012;17(1):13. doi: 10.1634/theoncologist.2011-0253. Epub 2011 Dec 30.

    PMID: 22210086RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Erlotinib HydrochlorideDocetaxel

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Limitations and Caveats

No statistical correlations with PFS and OS could be performed due to the small number of KRAS mutations.

Results Point of Contact

Title
Dr. EG Chiorean, MS
Organization
Hoosier Cancer Research Network, Inc.
jsmith@hoosiercancer.org
317-921-2050

Study Officials

  • Elena Gabriela Chiorean, M.D.

    Hoosier Oncology Group, LLC

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 20, 2007

Study Start

September 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 12, 2016

Results First Posted

February 12, 2016

Record last verified: 2016-01

Locations

US(12)