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Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101

Phase 2
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101

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


- Absolute neutrophil count (ANC) > 1000 mm3

- Platelet count > 75,000 mm3

- Hemoglobin > 8 g/dL


- 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


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


- Not specified

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

- 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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Elena Gabriela Chiorean, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

August 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Siteman Cancer CenterSaint Louis, Missouri  63110
Helen F. Graham Cancer CenterNewark, Delaware  19713
Methodist Cancer CenterOmaha, Nebraska  68114
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Medical Consultants, P.C.Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
IN Onc/Hem AssociatesIndianapolis, Indiana  46202
Rush-Presbyterian St. Luke's Medical CenterChicago, Illinois  60612