Liver CancerPhase 2NCT01180959
Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy
A Phase 2 study testing Bevacizumab and Erlotinib in people with Liver Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if the combination of AvastinTM (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver cancer. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Bevacizumab and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2011to 19 May 2021
- 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
- Patients with histological or cytologically documented HCC not amenable to curative resection (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. For subjects without cirrhosis, histological or cytological confirmation is mandatory.
- Patients must have measurable disease as per the modified RECIST criteria. Measurable target lesions are defined at baseline as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) >/= 20 mm using conventional techniques (CT or MRI) or >/= 10 mm using spiral CT scan. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation.
- Patients who have progressed on, or were intolerant to, one prior systemic therapy with sorafenib, completed ≥ 14 days prior to treatment day 1. Previous treatments also allowed that do not count as systemic therapy include: surgical resection, transarterial embolization/chemoembolization (TAE/TACE), radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), provided that the lesion(s) to be evaluated in this study are separate from the previously treated lesions(s).
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
- Childs-Pugh liver function status of A or B (only 7 points allowed).
- Organ function: Absolute peripheral granulocyte count of >/= 1500 mm^3, platelet count of >/= 40,000 mm^3, hemoglobin >/= 10 gm/dL. Total bilirubin </= 2.0 gm/dL; serum albumin >/= 2.5 gm/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) up to 5 X the upper limit of institutional normal (AST - 46 and ALT - 56); and prothrombin time prolonged not more than 3 seconds greater than institutional normal, once attempts to correct a prolonged PT have been made.
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- (Continuation of # 6) Patients who require full dose anticoagulation, who are otherwise eligible for this trial, are allowed to have an appropriately prolonged International Normalized Ratio (INR).
- Negative serum pregnancy test in women with childbearing potential (those who are not surgically sterilized or who are not amenorrheic for >/= 12 months), within one week prior to initiation of treatment.
- Men and women of childbearing potential must agree to use effective means of contraception prior to study entry and for at least 180 days after the last dose of study treatment. They must agree to use two forms of birth control, for example, barrier methods (such as a diaphragm, cervical cap, contraceptive sponge, female condom, or male condom), and an intrauterine device (IUD).
- Age >/= 18 years. The agents bevacizumab and erlotinib have not been studied in pediatric patients, thus the doses to be used in this study cannot be assumed to be safe in children.
- Radiographic evidence of disease progression during or following prior treatment with sorafenib.
- Patients must have proteinuria < 2+ or a urine protein:creatinine (UPC) ratio < 1.0. Patients who have proteinuria >/= 2+ and UPC ratio >/= 1.0 must undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible.
Who cannot join
- Patients who have had prior systemic therapy other than sorafenib. Patients may not have received any systemic chemotherapy </=14 days of Treatment Day 1.
- Active malignancy other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years.
- Current, recent (within 4 weeks of Treatment Day 1) or planned participation in an experimental drug study, other than this study.
- Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
- History of rupture of existing HCC lesion, or HCC lesion with large necrotic areas seen on conventional imaging studies, as determined by the Principal Investigator, if there is no measurable solid tumor area > 1.5 cm.
- Inadequately controlled hypertension (defined as systolic blood pressure >140 and/or diastolic blood pressure > 90).
Show all 30Show fewer
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- New York Heart Association Class II or greater congestive heart failure.
- Cardiac arrhythmia not controlled by medication.
- History of myocardial infarction or unstable angina within 6 months of Treatment Day 1.
- History of stroke or transient ischemic attack within 6 months prior to Day 1 of treatment.
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1.
- Evidence of clinically significant [Common Terminology Criteria (CTC) Grade 3 or 4] venous or arterial thrombotic disease within previous 6 months.
- Radiographic evidence of major tumor thrombus in the vena cava.
- History of hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- History of significant gastrointestinal bleeding requiring procedural intervention (eg variceal banding, Transjugular Intrahepatic Portosystemic Shunts (TIPS) procedure, arterial embolization) within three months prior to treatment day 1. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, radiographic evidence of cirrhosis, hypersplenism, or radiographic findings of varices) will be screened for esophageal varices.
- (Continuation of # 17) If varices are identified that require intervention (banding), that patient will not be eligible for the trial until the varices have been adequately treated.
- Known CNS disease, except for treated brain metastases. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator (LINAC), or equivalent) or a combination as deemed appropriate by the treating physician.
- (Continuation of # 20) Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study.
- Core biopsy, fine needle aspiration, or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
- Serious, non-healing wound, active ulcer, or untreated bone fracture.
- 0ngoing or active infection requiring parenteral therapy.
- Known HIV disease.
- Uncontrolled psychiatric illness.
- Known hypersensitivity to any component of bevacizumab and erlotinib.
- Pregnancy (positive pregnancy test) or lactation.
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Trial of Erlotinib Plus Bevacizumab in Advanced Hepatocellular Carcinoma as a Second-line Therapy in Patients Who Have Received First-line Sorafenib Therapy (AVF4572)
The goal of this clinical research study is to learn if the combination of AvastinTM (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver cancer. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing. There is a commercially available form of the drug (called Tarceva) that is expected to be very similar to the erlotinib being used for this study, but it is possible that there may be some differences between the 2 formulations.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drugs during 28-day "study cycles."
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes. If you do not have a reaction to the drug, such as fever and/or chills, the next dose will be given over about 60 minutes. If you still have no reaction after the second dose, each dose after that will be given over about 30 minutes. If you experience a reaction to the bevacizumab, you may be given Tylenol® (acetaminophen) by mouth and/or an antihistamine by vein over 30 minutes before each dose to help minimize the risk of further reactions.
You will take 1 erlotinib hydrochloride tablet by mouth every day. You should take erlotinib hydrochloride in the morning with a full glass of water (6-8oz) at least 1 hour before or 2 hours after any food, grapefruit juice, vitamins, iron supplements, or other non-prescription drugs.
Study Visits:
On Day 1 of Cycle 2 and beyond:
- Blood (about 3 tablespoons) will be drawn for routine blood tests and to check how well the blood clots.
- Urine will be collected for routine testing. A 24-hour urine sample may be collected if needed. If a 24-hour urine sample is needed, you will be provided with a special container to collect the sample.
- You will be asked questions about any side effects you may have had and about any drugs you may be currently taking or have taken since you last saw the study doctor.
- You will have a complete physical exam, including measurements of weight and vital signs.
- Your performance status will be recorded.
On Day 15 of Cycle 2 and beyond, your vital signs will be recorded.
At the end of Cycle 2, 4, and every 2 cycles after that (Cycles 6, 8, 10, and so on):
°You will have CT/MRI scans of the abdomen and pelvis and chest scan (if the doctor thinks they are needed) to check the status of the disease.
Additional tests may be done during the study if the study doctor thinks it is necessary.
Length of Treatment:
You will receive bevacizumab and erlotinib hydrochloride for as long as you are benefitting. There is no maximum number of cycles that you can receive. If you experience severe side effects, the treatment on this study may be delayed, stopped, or the study doctor may give you smaller doses of the study drugs. You will be taken off study if the disease gets worse, the side effects are too severe, or your doctor thinks that it is in your best interest to stop receiving treatment.
End-of-Treatment Visit:
After you stop receiving all of the study drugs, you will return for an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- Blood (about 3 tablespoons) and urine will be collected for routine tests and to learn how well the blood clots.
- You will be asked questions about any side effects you may have had and about any drugs you may be currently taking or have taken since you last saw the study doctor.
- You will have a complete physical exam, including measurements of weight and vital signs.
- Your performance status will be recorded.
- CT and/or MRI scans of the abdomen and pelvis will be performed to check the status of the disease.
Follow-Up:
After the end-of-treatment visit, the study doctor will continue to review your medical records every 3 months until the study analysis is complete. You will also be called every 3 months for as long as the study doctor thinks is needed. During these phone calls, you will be asked about how you are doing and if you are experiencing any health problems. The phone call should take about 15 minutes. During the follow-up period, if the study doctor thinks it is necessary, you may be asked to come in for a clinic visit.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colon and rectal cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of lung cancer. The use of this drug combination in patients with advanced liver cancer is investigational.
Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Liver Cancer
- Being tested
- Bevacizumab, Erlotinib
- Keywords
- Advanced Liver Cancer, primary neoplasm of the liver, Erlotinib, Bevacizumab, Hepatocellular Carcinoma, HCC, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, OSI-774, Tarceva
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
ErlotinibDrug
Also called OSI-774, Tarceva
150 mg by mouth once a day.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib + Bevacizumab | Experimental | Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes. Receives: Drug: Bevacizumab; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression-free survival is defined as time from initiation of therapy until documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 59 months
Secondary outcomes (2)
Time to Progression (TTP)
TTP is defined as the time between treatment assignment and radiologic progression at 16 weeks as defined by the amendments of the Response Evaluation Criteria in Solid Tumors (RECIST).Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 16 weeks
Overall Survival (OS)
Overall Survival is the time in months from start of study treatment to date of death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study start14 Apr 2011
- Primary completion19 May 2021
- Study completion19 May 2021
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 Liver CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ahmed Kaseb, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180959
- Sponsor's protocol ID
- 2009-0260
- Other IDs
- NCI-2011-00723
- Status last verified
- Nov 2022
- First submitted
- 11 Aug 2010
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kaseb AO, Morris JS, Iwasaki M, Al-Shamsi HO, Raghav KP, Girard L, Cheung S, Nguyen V, Elsayes KM, Xiao L, Abdel-Wahab R, Shalaby AS, Hassan M, Hassabo HM, Wolff RA, Yao JC. Phase II trial of bevacizumab and erlotinib as a second-line therapy for advanced hepatocellular carcinoma. Onco Targets Ther. 2016 Feb 15;9:773-80. doi: 10.2147/OTT.S91977. eCollection 2016.
PubMed 26929648
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Erlotinib Plus Bevacizumab in Advanced Hepatocellular Carcinoma as a Second-line Therapy in Patients Who Have Received First-line Sorafenib Therapy (AVF4572)
- ClinicalTrials.gov ID
- NCT01180959
- Acronym / sponsor ID
- 2009-0260
- Conditions
- Liver Cancer
- Keywords
- Advanced Liver Cancer, primary neoplasm of the liver, Erlotinib, Bevacizumab, Hepatocellular Carcinoma, HCC, Avastin, Anti-VEGF monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Study start
- 14 Apr 2011 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Posted 7 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if the combination of AvastinTM (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver cancer. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing. There is a commercially available form of the drug (called Tarceva) that is expected to be very similar to the erlotinib being used for this study, but it is possible that there may be some differences between the 2 formulations.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drugs during 28-day "study cycles."
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes. If you do not have a reaction to the drug, such as fever and/or chills, the next dose will be given over about 60 minutes. If you still have no reaction after the second dose, each dose after that will be given over about 30 minutes. If you experience a reaction to the bevacizumab, you may be given Tylenol® (acetaminophen) by mouth and/or an antihistamine by vein over 30 minutes before each dose to help minimize the risk of further reactions.
You will take 1 erlotinib hydrochloride tablet by mouth every day. You should take erlotinib hydrochloride in the morning with a full glass of water (6-8oz) at least 1 hour before or 2 hours after any food, grapefruit juice, vitamins, iron supplements, or other non-prescription drugs.
Study Visits:
On Day 1 of Cycle 2 and beyond:
- Blood (about 3 tablespoons) will be drawn for routine blood tests and to check how well the blood clots.
- Urine will be collected for routine testing. A 24-hour urine sample may be collected if needed. If a 24-hour urine sample is needed, you will be provided with a special container to collect the sample.
- You will be asked questions about any side effects you may have had and about any drugs you may be currently taking or have taken since you last saw the study doctor.
- You will have a complete physical exam, including measurements of weight and vital signs.
- Your performance status will be recorded.
On Day 15 of Cycle 2 and beyond, your vital signs will be recorded.
At the end of Cycle 2, 4, and every 2 cycles after that (Cycles 6, 8, 10, and so on):
°You will have CT/MRI scans of the abdomen and pelvis and chest scan (if the doctor thinks they are needed) to check the status of the disease.
Additional tests may be done during the study if the study doctor thinks it is necessary.
Length of Treatment:
You will receive bevacizumab and erlotinib hydrochloride for as long as you are benefitting. There is no maximum number of cycles that you can receive. If you experience severe side effects, the treatment on this study may be delayed, stopped, or the study doctor may give you smaller doses of the study drugs. You will be taken off study if the disease gets worse, the side effects are too severe, or your doctor thinks that it is in your best interest to stop receiving treatment.
End-of-Treatment Visit:
After you stop receiving all of the study drugs, you will return for an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- Blood (about 3 tablespoons) and urine will be collected for routine tests and to learn how well the blood clots.
- You will be asked questions about any side effects you may have had and about any drugs you may be currently taking or have taken since you last saw the study doctor.
- You will have a complete physical exam, including measurements of weight and vital signs.
- Your performance status will be recorded.
- CT and/or MRI scans of the abdomen and pelvis will be performed to check the status of the disease.
Follow-Up:
After the end-of-treatment visit, the study doctor will continue to review your medical records every 3 months until the study analysis is complete. You will also be called every 3 months for as long as the study doctor thinks is needed. During these phone calls, you will be asked about how you are doing and if you are experiencing any health problems. The phone call should take about 15 minutes. During the follow-up period, if the study doctor thinks it is necessary, you may be asked to come in for a clinic visit.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colon and rectal cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of lung cancer. The use of this drug combination in patients with advanced liver cancer is investigational.
Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib + Bevacizumab | Experimental | Drug: Bevacizumab, Drug: ErlotinibErlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with histological or cytologically documented HCC not amenable to curative resection (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. For subjects without cirrhosis, histological or cytological confirmation is mandatory.
- Patients must have measurable disease as per the modified RECIST criteria. Measurable target lesions are defined at baseline as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) >/= 20 mm using conventional techniques (CT or MRI) or >/= 10 mm using spiral CT scan. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation.
- Patients who have progressed on, or were intolerant to, one prior systemic therapy with sorafenib, completed ≥ 14 days prior to treatment day 1. Previous treatments also allowed that do not count as systemic therapy include: surgical resection, transarterial embolization/chemoembolization (TAE/TACE), radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), provided that the lesion(s) to be evaluated in this study are separate from the previously treated lesions(s).
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
- Childs-Pugh liver function status of A or B (only 7 points allowed).
Key exclusion criteria (30 listed)
- Patients who have had prior systemic therapy other than sorafenib. Patients may not have received any systemic chemotherapy </=14 days of Treatment Day 1.
- Active malignancy other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years.
- Current, recent (within 4 weeks of Treatment Day 1) or planned participation in an experimental drug study, other than this study.
- Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
- History of rupture of existing HCC lesion, or HCC lesion with large necrotic areas seen on conventional imaging studies, as determined by the Principal Investigator, if there is no measurable solid tumor area > 1.5 cm.
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 |
|---|---|---|
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes | Drug | Erlotinib + Bevacizumab |
| ErlotinibAlso: OSI-774, Tarceva150 mg by mouth once a day. | Drug | Erlotinib + Bevacizumab |
Primary outcome
Progression Free Survival (PFS)
Time frame: 59 months
Progression-free survival is defined as time from initiation of therapy until documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
2 secondary outcomes
Time to Progression (TTP)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 16 weeks
Overall Survival (OS)
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26929648Kaseb AO, Morris JS, Iwasaki M, Al-Shamsi HO, Raghav KP, Girard L, Cheung S, Nguyen V, Elsayes KM, Xiao L, Abdel-Wahab R, Shalaby AS, Hassan M, Hassabo HM, Wolff RA, Yao JC. Phase II trial of bevacizumab and erlotinib as a second-line therapy for advanced hepatocellular carcinoma. Onco Targets Ther. 2016 Feb 15;9:773-80. doi: 10.2147/OTT.S91977. eCollection 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Ahmed Kaseb, MBBS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Erlotinib in people with Liver Cancer, run by M.D. Anderson Cancer Center at 1 site 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 12 inclusion and 30 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: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Nov 2022). 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?
Progression Free Survival (PFS) (time frame: 59 months). 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 NCT01180959, 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 7 Nov 2022.