Hepatocellular CarcinomaPhase 2NCT00532441
Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas
A Phase 2 study testing Erlotinib and Docetaxel in people with Hepatocellular Carcinoma, run by Gabi Chiorean, MD at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Erlotinib and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
IN Onc/Hem Associates
Indianapolis, Indiana, 46202
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Medical Consultants, P.C.
Muncie, Indiana, 47303
Helen F. Graham Cancer Center
Newark, Delaware, 19713
Methodist Cancer Center
Omaha, Nebraska, 68114
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101
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.
Read the 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: 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
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
DocetaxelDrug
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Erlotinib; Drug: 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 Receives: Drug: Erlotinib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of treatment until disease progression per RECIST criteria up to 16 weeks
Secondary outcomes (2)
Response Rate
Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Measured: 18 months
Overall Survival
Determine Overall Survival
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Terminated due to funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabi Chiorean, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, OSI Pharmaceuticals
- Responsible party
- Sponsor-investigator, Gabi Chiorean, MD, Hoosier Cancer Research Network
- Investigators
- Elena Gabriela Chiorean, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532441
- Sponsor's protocol ID
- GI06-101
- Status last verified
- Jan 2016
- First submitted
- 18 Sep 2007
- Last updated
- 12 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22210086
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101
- ClinicalTrials.gov ID
- NCT00532441
- Acronym / sponsor ID
- GI06-101
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to funding issues.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gabi Chiorean, MDUniversity, hospital or other
- Collaborators
- Sanofi, OSI Pharmaceuticals
- Study start
- Sep 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Posted 12 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib and Docetaxel: Biliary | Experimental | Drug: Erlotinib, Drug: DocetaxelErlotinib 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 |
| Erlotinib and Docetaxel: Hepatocellular | Experimental | Drug: Erlotinib, Drug: DocetaxelErlotinib 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibErlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 | Drug | Erlotinib and Docetaxel: Biliary, Erlotinib and Docetaxel: Hepatocellular |
| DocetaxelDocetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 | Drug | Erlotinib and Docetaxel: Biliary, Erlotinib and Docetaxel: Hepatocellular |
Primary outcome
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.
2 secondary outcomes
Response Rate
Time frame: 18 months
Overall Survival
Time frame: 18 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22210086Chiorean 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.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Gabriela Chiorean, M.D. study chair
Hoosier Oncology Group, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and Docetaxel in people with Hepatocellular Carcinoma, run by Gabi Chiorean, MD at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16 Weeks Progression-free Survival (time frame: Start of treatment until disease progression per RECIST criteria up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.