Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas
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ClinicalTrials.gov Identifier: NCT00532441 |
Recruitment Status :
Terminated
(Terminated due to funding issues.)
First Posted : September 20, 2007
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Drug: Erlotinib Drug: Docetaxel | Phase 2 |
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: Eastern Cooperative Oncology Group (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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101 |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Erlotinib and Docetaxel: Biliary
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: 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 |
Experimental: Erlotinib and Docetaxel: Hepatocellular
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: 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 |
- 16 Weeks Progression-free Survival [ Time Frame: Start of treatment until disease progression per RECIST criteria up to 16 weeks ]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.
- Response Rate [ Time Frame: 18 months ]Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
- Overall Survival [ Time Frame: 18 Months ]Determine Overall Survival

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532441
United States, Delaware | |
Helen F. Graham Cancer Center | |
Newark, Delaware, United States, 19713 | |
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
Rush-Presbyterian St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Cancer Care Center of Southern Indiana | |
Bloomington, Indiana, United States, 47403 | |
Fort Wayne Oncology & Hematology, Inc | |
Fort Wayne, Indiana, United States, 46815 | |
IN Onc/Hem Associates | |
Indianapolis, Indiana, United States, 46202 | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
Quality Cancer Center (MCGOP) | |
Indianapolis, Indiana, United States, 46202 | |
Medical Consultants, P.C. | |
Muncie, Indiana, United States, 47303 | |
Northern Indiana Cancer Research Consortium | |
South Bend, Indiana, United States, 46601 | |
United States, Missouri | |
Siteman Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 |
Study Chair: | Elena Gabriela Chiorean, M.D. | Hoosier Oncology Group, LLC |
Publications of Results:
Responsible Party: | Gabi Chiorean, MD, Principal Investigator, Hoosier Cancer Research Network |
ClinicalTrials.gov Identifier: | NCT00532441 |
Other Study ID Numbers: |
GI06-101 |
First Posted: | September 20, 2007 Key Record Dates |
Results First Posted: | February 12, 2016 |
Last Update Posted: | February 12, 2016 |
Last Verified: | January 2016 |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Docetaxel Erlotinib Hydrochloride Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |