Advanced CancerPhase 1NCT01152203
Bendamustine and Bevacizumab for Advanced Cancers
A Phase 1 study testing Bendamustine and Bevacizumab in people with Advanced 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 find the highest tolerable combination dose of bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Bendamustine and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed cancer.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities). Pediatric: performance status Karnovsky (>10) or Lansky (<10).
- Adequate renal function (serum creatinine </= 2.0 mg/dL or the calculated Glomerular Filtration Rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL). Pediatric: serum creatinine </= 1.5 mg/dL or 2x upper limit of normal, for age.
- Hepatic function: total bilirubin </= 1.0 mg/dL (Patients with Gilbert's Syndrome must have a total bilirubin </= 3.0 mg/dL); ALT </= 3 times upper limit of normal. If patient has liver metastases, total bilirubin </= 5 mg/dL; ALT </= 5 times upper limit of normal.
- Adequate bone marrow function (Absolute neutrophil count (ANC) >/= 1,000 cells/uL; Platelets (PLT) >/= 75,000 cells/uL), unless these abnormalities are due to bone marrow involvement.
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- At least three weeks from previous cytotoxic chemotherapy. After targeted or biologic therapy there should be 5 half-lives or 3 weeks, whichever is shorter.
- All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
- Must be >/= 13 years of age.
- Sign informed consent. Pediatric participants: age 13-17 would sign assent, parent or guardian would sign consent.
Who cannot join
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Serious or non-healing wound, ulcer or bone fracture.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg).
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
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- Patients with clinical bleeding, active gastric or duodenal ulcer.
- Patients with history of bleeding central nervous system (CNS) metastasis will be excluded from the trial.
- Patients with major surgery within 28 days prior to entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers
The goal of this clinical research study is to find the highest tolerable combination dose of bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
Read the detailed description
The Study Drugs:
Bendamustine is designed to damage DNA (the genetic material) of cancer cells. Bendamustine also interferes with the creation of new DNA, which may keep cancer cells from repairing themselves or forming new cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply the nutrients needed for tumor growth, which may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of bendamustine based on when you join this study. Up to 4 dose levels of bendamustine will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of bendamustine is found.
All participants will receive the same dose level of bevacizumab.
Study Drug Administration:
You will receive bendamustine by vein over 30-60 minutes on Days 1 and 2 of each 28-day study cycle.
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
Study Visits:
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 tablespoon ) will be drawn for routine tests.
- Women who are able to become pregnant will have a urine pregnancy test.
Every 2 cycles (Cycles 2, 4, 6, and so on):
- Blood (about 1 tablespoon) will be drawn to test for tumor markers.
- A chest x-ray, CT scan, MRI scan, PET scan, and/or PET/CT scan will be performed to check the status of the disease. These scans will also be performed at any time that the doctor thinks it is needed to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans that have not been listed here may also be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Follow-Up Visit:
Six (6) weeks after you stop taking the study drug combination for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan and/or PET/CT scan will be performed to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans that have not been listed here may also be performed.
This is an investigational study. Bendamustine is FDA approved and commercially available for the treatment of chronic lymphoid leukemia and non-Hodgkin's lymphoma. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colorectal cancer, non-small-cell lung cancer (NSCLC), and a type of brain cancer called glioblastoma multiforme. The use of these drugs in combination in advanced cancer is investigational.
Up to 55 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Bendamustine, Bevacizumab
- Keywords
- Bendamustine, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Bendamustine hydrochloride, Bendamustine HCI, CEP-18083, SDX-105
Starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10 mg/kg by vein on Days 1 \& 15 of every 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine + Bevacizumab | Experimental | Bendamustine starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle. Bevacizumab 10 mg/kg by vein on Days 1 \& 15 of every 28 day cycle. Receives: Drug: Bendamustine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Bendamustine and Bevacizumab
MTD defined as highest dose below any dose that has one third or more patients with dose limiting toxicity (DLT). If not more than 33% of the patients in the cohort develop DLT, this cohort considered MTD. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in most current version of NCI Common Toxicity Criteria for Adverse Effects (CTCAE).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Apostolia M. Tsimberidou, MD, PhD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152203
- Sponsor's protocol ID
- 2009-0979
- Other IDs
- NCI-2010-01690
- Status last verified
- May 2014
- First submitted
- 25 Jun 2010
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT01152203
- Acronym / sponsor ID
- 2009-0979
- Conditions
- Advanced Cancer
- Keywords
- Bendamustine, Bevacizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon, National Comprehensive Cancer Network
- Study start
- Jun 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
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 find the highest tolerable combination dose of bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
Detailed description
The Study Drugs:
Bendamustine is designed to damage DNA (the genetic material) of cancer cells. Bendamustine also interferes with the creation of new DNA, which may keep cancer cells from repairing themselves or forming new cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply the nutrients needed for tumor growth, which may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of bendamustine based on when you join this study. Up to 4 dose levels of bendamustine will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of bendamustine is found.
All participants will receive the same dose level of bevacizumab.
Study Drug Administration:
You will receive bendamustine by vein over 30-60 minutes on Days 1 and 2 of each 28-day study cycle.
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
Study Visits:
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 tablespoon ) will be drawn for routine tests.
- Women who are able to become pregnant will have a urine pregnancy test.
Every 2 cycles (Cycles 2, 4, 6, and so on):
- Blood (about 1 tablespoon) will be drawn to test for tumor markers.
- A chest x-ray, CT scan, MRI scan, PET scan, and/or PET/CT scan will be performed to check the status of the disease. These scans will also be performed at any time that the doctor thinks it is needed to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans that have not been listed here may also be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Follow-Up Visit:
Six (6) weeks after you stop taking the study drug combination for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan and/or PET/CT scan will be performed to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans that have not been listed here may also be performed.
This is an investigational study. Bendamustine is FDA approved and commercially available for the treatment of chronic lymphoid leukemia and non-Hodgkin's lymphoma. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colorectal cancer, non-small-cell lung cancer (NSCLC), and a type of brain cancer called glioblastoma multiforme. The use of these drugs in combination in advanced cancer is investigational.
Up to 55 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine + Bevacizumab | Experimental | Drug: Bendamustine, Drug: BevacizumabBendamustine starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle. Bevacizumab 10 mg/kg by vein on Days 1 \& 15 of every 28 day cycle. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically confirmed cancer.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities). Pediatric: performance status Karnovsky (>10) or Lansky (<10).
- Adequate renal function (serum creatinine </= 2.0 mg/dL or the calculated Glomerular Filtration Rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL). Pediatric: serum creatinine </= 1.5 mg/dL or 2x upper limit of normal, for age.
- Hepatic function: total bilirubin </= 1.0 mg/dL (Patients with Gilbert's Syndrome must have a total bilirubin </= 3.0 mg/dL); ALT </= 3 times upper limit of normal. If patient has liver metastases, total bilirubin </= 5 mg/dL; ALT </= 5 times upper limit of normal.
Key exclusion criteria (9 listed)
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Serious or non-healing wound, ulcer or bone fracture.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg).
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| BendamustineAlso: Bendamustine hydrochloride, Bendamustine HCI, CEP-18083, SDX-105Starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle | Drug | Bendamustine + Bevacizumab |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF10 mg/kg by vein on Days 1 \& 15 of every 28 day cycle | Drug | Bendamustine + Bevacizumab |
Primary outcome
Maximum Tolerated Dose (MTD) of Bendamustine and Bevacizumab
Time frame: 28 days
MTD defined as highest dose below any dose that has one third or more patients with dose limiting toxicity (DLT). If not more than 33% of the patients in the cohort develop DLT, this cohort considered MTD. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in most current version of NCI Common Toxicity Criteria for Adverse Effects (CTCAE).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- 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.
Apostolia M. Tsimberidou, MD, PhD study chair
UT MD 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 1 study testing Bendamustine and Bevacizumab in people with Advanced 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 10 inclusion and 9 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 18 Nov 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) of Bendamustine and Bevacizumab (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2015.