Advanced CancerPhase 1NCT00610493
Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
A Phase 1 study testing Bevacizumab, Temsirolimus and Additional Blood Drawn 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 dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Bevacizumab, Temsirolimus and Additional Blood Drawn
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2008to 28 Nov 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
- Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- ECOG performance status </= 2 (Karnofsky >/= 60%).
- Patients must have allowable organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 3 X ULN; total bilirubin </= 3.0; AST(SGOT)/ALT(SGPT) </= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document
- Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.
Who cannot join
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
- Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
- Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris
- Pregnant or lactating women.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to Temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation
- Patients that are taking CYP3A4 inducers and/or inhibitors. Please see section 3.2 in the protocol for details. If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol.
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 I Trial of Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
The goal of this clinical research study is to find the highest tolerable dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients necessary for tumor growth.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of bevacizumab and temsirolimus combined, based on when you joined this study. Up to 13 dose levels of the study drug combination will be tested. Three (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 the study drug combination is found.
If you choose to enroll in the expansion group of patients being treated at the highest tolerable dose of the study drug combination found, you will be required to undergo added testing, as follows:
- You will have additional blood drawn (about 2 teaspoons each time) during Cycle 1. This blood will be drawn before you begin taking the study drugs; on Day 1 at about 1, 4, 8, and 24 hours after the start of your first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at the end of Cycle 1. The blood will be used to see how the study drug combination acts in the body and to learn its effect on cancer cells.
- You will have 2 tumor biopsies performed. These samples will be used to see how the study drug combination acts in the body and to learn its effect on cancer cells. These tumor biopsies will be performed during the screening visit and at the end of Cycle 1. To perform a tumor biopsy, the affected area is numbed with anesthetic and some or all of the tumor tissue is removed with a small knife.
- You will have extra imaging scans performed and used to see how the study drug combination may be affecting blood vessels that supply nutrients and oxygen to cancer. A DCE-MRI scan will be performed during the screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Like a regular MRI scan, the DCE-MRI scan involves passing part or all of the body into a long, narrow tube scanner that is open at both ends.
Study Drug Administration:
Bevacizumab and temsirolimus will be given in "cycles." Cycles will be about 21 days long or longer, depending on any side effects you may experience.
Bevacizumab is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 90 minutes. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 30 minutes in Cycle 3. It will continue to be given over 30 minutes in Cycle 4 and further cycles, as long as you still tolerate it well. Also, if the first dose is well tolerated, you may be given the remaining doses of Bevacizumab in the doctor's office in or near your hometown.
Temsirolimus is given by vein on Days 1, 8, and 15 of each cycle. During Day 1 of Cycle 1, you will receive it over 60 minutes. If you tolerate it well on Day 1 of Cycle 1, it will be given over 30 minutes on Days 8 and 15 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well. Also, if the first dose is well tolerated, you may be given the remaining doses of Temsirolimus in the doctor's office in or near your hometown.
Study Visits:
You will have a physical exam and blood drawn (about 1 tablespoon each time) for routine tests once between Days 7 and 14 during Cycle 1. During the rest of the cycles, you will have a physical exam and blood drawn (about 1 tablespoon each time) for routine tests once every 3 weeks. The status of the disease will be checked by a CT or MRI scan after every 2 cycles, starting after Cycle 2.
Length of Study Participation:
You may continue to receive additional cycles of the study drugs, unless the cancer gets worse or intolerable side effects occur. In that case, you will be taken off study.
Once your participation is over in this study, you will receive standard-of-care follow-up for the disease.
This is an investigational study. Bevacizumab and temsirolimus are commercially available. Bevacizumab is FDA approved for the treatment of colorectal cancer and a type of lung cancer. Temsirolimus is FDA approved for the treatment of kidney cancer that has spread. The combination of bevacizumab and temsirolimus is not FDA approved. At this time, it is being used in research only.
Up to 183 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Bevacizumab, Temsirolimus, Additional Blood Drawn, Biopsy, DCE-MRI Scan
- Keywords
- Advanced Cancer, Bevacizumab, Temsirolimus, Avastin, Torisel, CCI-779, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, dynamic contrast-enhanced magnetic resonance imaging, DCE, magnetic resonance imaging, MRI
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
5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle
TemsirolimusDrug
Also called Torisel, CCI-779
5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle
Additional Blood DrawnProcedure or surgery
2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1.
BiopsyProcedure or surgery
First tumor biopsy during screening visit and Second at the end of Cycle 1
DCE-MRI ScanProcedure or surgery
Also called imaging scans, dynamic contrast-enhanced magnetic resonance imaging, DCE, magnetic resonance imaging
DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + Temsirolimus | Experimental | Bevacizumab 5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle. Temsirolimus 5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle. First tumor biopsy during screening visit and Second at the end of Cycle 1. DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Receives: Drug: Bevacizumab; Drug: Temsirolimus; Procedure: Additional Blood Drawn; Procedure: Biopsy; Procedure: DCE-MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Maximum tolerated dose defined as the dose level below the dose at which two of six patients experience drug-related dose limiting toxicity in the first cycle.
Measured: 21 days
Secondary outcomes (1)
Anti-Tumor Efficacy
Anti-tumor efficacy of each combination determined by objective response per RECIST and WHO criteria.
Measured: Baseline, 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Cycles are 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study start25 Jan 2008
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
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
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarina Piha-Paul, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610493
- Sponsor's protocol ID
- 2007-0668
- Other IDs
- NCI-2012-01750
- Status last verified
- Dec 2017
- First submitted
- 25 Jan 2008
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT00610493
- Acronym / sponsor ID
- 2007-0668
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Bevacizumab, Temsirolimus, Avastin, Torisel, CCI-779, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Jan 2008 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 8 Feb 2008 (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 dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients necessary for tumor growth.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of bevacizumab and temsirolimus combined, based on when you joined this study. Up to 13 dose levels of the study drug combination will be tested. Three (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 the study drug combination is found.
If you choose to enroll in the expansion group of patients being treated at the highest tolerable dose of the study drug combination found, you will be required to undergo added testing, as follows:
- You will have additional blood drawn (about 2 teaspoons each time) during Cycle 1. This blood will be drawn before you begin taking the study drugs; on Day 1 at about 1, 4, 8, and 24 hours after the start of your first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at the end of Cycle 1. The blood will be used to see how the study drug combination acts in the body and to learn its effect on cancer cells.
- You will have 2 tumor biopsies performed. These samples will be used to see how the study drug combination acts in the body and to learn its effect on cancer cells. These tumor biopsies will be performed during the screening visit and at the end of Cycle 1. To perform a tumor biopsy, the affected area is numbed with anesthetic and some or all of the tumor tissue is removed with a small knife.
- You will have extra imaging scans performed and used to see how the study drug combination may be affecting blood vessels that supply nutrients and oxygen to cancer. A DCE-MRI scan will be performed during the screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Like a regular MRI scan, the DCE-MRI scan involves passing part or all of the body into a long, narrow tube scanner that is open at both ends.
Study Drug Administration:
Bevacizumab and temsirolimus will be given in "cycles." Cycles will be about 21 days long or longer, depending on any side effects you may experience.
Bevacizumab is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 90 minutes. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 30 minutes in Cycle 3. It will continue to be given over 30 minutes in Cycle 4 and further cycles, as long as you still tolerate it well. Also, if the first dose is well tolerated, you may be given the remaining doses of Bevacizumab in the doctor's office in or near your hometown.
Temsirolimus is given by vein on Days 1, 8, and 15 of each cycle. During Day 1 of Cycle 1, you will receive it over 60 minutes. If you tolerate it well on Day 1 of Cycle 1, it will be given over 30 minutes on Days 8 and 15 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well. Also, if the first dose is well tolerated, you may be given the remaining doses of Temsirolimus in the doctor's office in or near your hometown.
Study Visits:
You will have a physical exam and blood drawn (about 1 tablespoon each time) for routine tests once between Days 7 and 14 during Cycle 1. During the rest of the cycles, you will have a physical exam and blood drawn (about 1 tablespoon each time) for routine tests once every 3 weeks. The status of the disease will be checked by a CT or MRI scan after every 2 cycles, starting after Cycle 2.
Length of Study Participation:
You may continue to receive additional cycles of the study drugs, unless the cancer gets worse or intolerable side effects occur. In that case, you will be taken off study.
Once your participation is over in this study, you will receive standard-of-care follow-up for the disease.
This is an investigational study. Bevacizumab and temsirolimus are commercially available. Bevacizumab is FDA approved for the treatment of colorectal cancer and a type of lung cancer. Temsirolimus is FDA approved for the treatment of kidney cancer that has spread. The combination of bevacizumab and temsirolimus is not FDA approved. At this time, it is being used in research only.
Up to 183 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 |
|---|---|---|
| Bevacizumab + Temsirolimus | Experimental | Drug: Bevacizumab, Drug: Temsirolimus, Procedure: Additional Blood Drawn, Procedure: Biopsy, Procedure: DCE-MRI ScanBevacizumab 5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle. Temsirolimus 5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle. First tumor biopsy during screening visit and Second at the end of Cycle 1. DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
- Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- ECOG performance status </= 2 (Karnofsky >/= 60%).
- Patients must have allowable organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 3 X ULN; total bilirubin </= 3.0; AST(SGOT)/ALT(SGPT) </= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
Key exclusion criteria (8 listed)
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
- Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
- Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris
- Pregnant or lactating women.
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-VEGF5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle | Drug | Bevacizumab + Temsirolimus |
| TemsirolimusAlso: Torisel, CCI-7795 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle | Drug | Bevacizumab + Temsirolimus |
| Additional Blood Drawn2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1. | Procedure or surgery | Bevacizumab + Temsirolimus |
| BiopsyFirst tumor biopsy during screening visit and Second at the end of Cycle 1 | Procedure or surgery | Bevacizumab + Temsirolimus |
| DCE-MRI ScanAlso: imaging scans, dynamic contrast-enhanced magnetic resonance imaging, DCE, magnetic resonance imagingDCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1 | Procedure or surgery | Bevacizumab + Temsirolimus |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 21 days
Maximum tolerated dose defined as the dose level below the dose at which two of six patients experience drug-related dose limiting toxicity in the first cycle.
1 secondary outcome
Anti-Tumor Efficacy
Time frame: Baseline, 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Cycles are 21 days.
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 8 Dec 2017.
- 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.
Sarina Piha-Paul, MD 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 1 study testing Bevacizumab, Temsirolimus and Additional Blood Drawn 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 7 inclusion and 8 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 8 Dec 2017. 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) (time frame: 21 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 8 Dec 2017.