Advanced CancerPhase 1NCT01187199
Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer
A Phase 1 study testing Temsirolimus, Bevacizumab and Paclitaxel 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 the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Temsirolimus, Bevacizumab and Paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2010to 30 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Inclusion: (For all treatment arms)
- 1.1 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.
- 1.2 Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation does not target the only measurable or evaluable disease.
- 1.3 Patients must have measurable or evaluable disease
- 1.4 ECOG performance status </= 2 (Karnofsky >/= 60%, Lansky >/= 50%).
- 1.5 Patients must have normal organ function defined as: creatinine </= 1.5 x ULN for children and </= 2.0 x ULN for adults; total bilirubin </= 2.0; ALT(SGPT)/AST (SGOT) </= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT/AST may be elevated as high as 8 X ULN.
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- 1.6 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.
- 1.7 Ability to understand and the willingness to sign a written informed consent document.
- 1.8 Life expectancy of at least 3 months.
- 1.9 Patients may not be receiving any other experimental agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance.
- Inclusion: (For carboplatin and paclitaxel arms)
- 2.1 Patients must have normal marrow function defined as: absolute neutrophil count >/= 1,500/mL; platelets >/= 100,000/mL.
- 2.2 Patient with neuropathies of CTC grade 1 or less.
- Inclusion: (For sorafenib arm)
- 3.1 Patients must have normal marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/= 75,000/mL.
Who cannot join
- Exclusion: (For all treatment arms)
- 4.1 Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
- 4.2 Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
- 4.3 Patients with clinically significant cardiovascular disease: History of CVA within 6 months Myocardial infarction or unstable angina within 6 months Unstable angina pectoris New York Heart Association Class > II
- 4.4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- 4.5 Pregnant or lactating women.
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- 4.6 History of hypersensitivity to bevacizumab or murine products, temsirolimus or its metabolites, or any component of the formulation.
- 4.7 Patients with hemorrhagic brain metastases.
- 4.8 Patients with prior abdominal surgery within 30 days prior to entering the study.
- 4.9 Medications with potent inducer or inhibitor of P450 3A4 should be avoided within 5 half lives of temsirolimus.
- Exclusion: (For carboplatin treatment arm)
- 5.1 Hypersensitivity to carboplatin or any component of the formulation.
- Exclusion: (For paclitaxel treatment arm)
- 6.1 Hypersensitivity to paclitaxel or any component of the formulation.
- Exclusion: (For sorafenib treatment arm)
- 7.1 History of hypersensitivity to sorafenib or any component of the formulation.
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
The goal of this clinical research study is to find the highest tolerable dose of the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The safety of these drug combinations 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.
Temsirolimus is designed to block the growth of cancer cells, which may eventually cause the cancer cells to die.
Carboplatin is designed to damage the DNA (the genetic material of cells)of cancer cells, which may will eventually cause the cancer cells to die.
Paclitaxel is designed to damage the DNA of cancer cells, which may eventually cause the cancer cells to die.
Sorafenib is designed to block the function of important proteins in cancer cells. These proteins, when active, are in part responsible for the abnormal growth and behavior of cancer cells.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, your doctor will decide which study drugs you will receive based on the disease type and on the drugs you have taken in the past.
Every participant will receive bevacizumab and temsirolimus. The study staff will tell you which of the other 3 drugs (carboplatin, paclitaxel, or sorafenib) you will receive.
Once it is decided which drugs you will receive, you will be assigned to a dose level of the drug combination based on when you join this study. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants on each drug combination will receive the lowest doses. 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 each dose combination is found.
Your dose of study drugs may be lowered later, if you do not tolerate the study drug combination well.
Once the highest tolerated dose is found for each group, up to 10 more participants will be added to each group at that dose level. This is called an extension group.
Study Drug Administration:
Each cycle is about 21 days or 28 days, depending on which study drug combination you receive.If you experience side effects, the start of the next cycle may be delayed. Your doctor will tell you on which dose level you will be assigned.
SORAFENIB ARM:
If you are assigned to take sorafenib, you will take it by mouth 1 or 2 times every day (the study staff will tell you how often to take it). You should take sorafenib on an empty stomach, either 1 hour before a meal or 2 hours after a meal.
On Day 1 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus by vein. 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.
CARBOPLATIN ARM:
If you are assigned to take carboplatin,you will receive it by vein over 1 hour on Day 1 of each cycle.
On Day 1 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus by vein. 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.
PACLITAXEL ARM DOSE LEVELS 1-8:
If you are assigned to take paclitaxel on Dose Levels 1 - 8, you will receive it by vein over 3 hours on Days 1, 8, and 15 of each cycle.
On Day 1 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus by vein. 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.
PACLITAXEL ARM DOSE LEVELS 9 - 13:
If you are assigned to take paclitaxel on Dose Levels 9 - 13, you will receive paclitaxel by vein over 3 hours on Days 1, 8, and 15 of each cycle.
On Days 1 and 15 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, 15, and 22 of each cycle, you will receive temsirolimus by vein. 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, 15, and 22 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well.
Study Visits:
During Cycle 1:
- Urine will be collected for routine tests on Day 1.
- You will have a physical exam, including measurement of your weight and vital signs (blood pressure, breathing rate, heart rate, and temperature).
- You will be asked how well you are able to perform the normal activities of daily living (performance status) on Days 1 and 8.
- Blood (about 1 tablespoon) will be drawn for routine tests on Days 1, 8, and 15.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam, including of your weight and vital signs..
- Your performance status will be recorded.
- Blood (about 1 tablespoon) and urine will be collected for routine tests
After Cycle 2, you will have a CT scan or MRI scan to check the status of the disease every 2-3 cycles. After 6 months, this may be performed up to every 4 cycles if the doctor thinks it is in your best interest.
Length of Study:
You may remain on study for as long as the doctor thinks it is in you best interest. You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Bevacizumab, temsirolimus, carboplatin, paclitaxel, and sorafenib are all 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. Carboplatin is FDA approved for the treatment of ovarian cancer or non-small cell lung cancer. Paclitaxel is FDA approved for ovarian, breast cancer, and AIDS-related Kaposi's sarcoma. It is also approved in combination with cisplatin for the treatment of ovarian and non-small cell lung cancer. Sorafenib is FDA approved for the treatment of kidney cancer.
The use of these drugs together is investigational.
Up to 278 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Temsirolimus, Bevacizumab, Paclitaxel, Sorafenib, Carboplatin
- Keywords
- Metastatic cancer, Chemotherapy, Avastin, Carboplatin, Paclitaxel, Sorafenib, Temsirolimus
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Also called CCI-779, Torisel
Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
PaclitaxelDrug
Also called Taxol
Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle.
SorafenibDrug
Also called Nexavar, BAY 43-9006
Starting dose 200 mg by mouth daily for a 21 day cycle.
CarboplatinDrug
Also called Paraplatin
Starting dose AUC 2 by vein on day 1 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin Group | Experimental | Carboplatin: Starting dose AUC 2 by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. Receives: Drug: Temsirolimus; Drug: Bevacizumab; Drug: Carboplatin |
| Paclitaxel Group | Experimental | Paclitaxel: Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. Receives: Drug: Temsirolimus; Drug: Bevacizumab; Drug: Paclitaxel |
| Sorafenib Group | Experimental | Sorafenib: Starting dose 200 mg by mouth daily for a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. Receives: Drug: Temsirolimus; Drug: Bevacizumab; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD defined by dose-limiting toxicities (DLTs) that occur during the first four weeks of therapy. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v4.0.
Measured: 4 weeks
Secondary outcomes (3)
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Carboplatin
Anti-tumor efficacy of each drug combination assessed by the WHO criteria if participant has lymphoma.
Anti-tumor efficacy of each drug combination assessed by the RECIST criteria for all other cancers.
Measured: 56 days
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Paclitaxel
Anti-tumor efficacy of each drug combination assessed by the WHO criteria if participant has lymphoma.
Anti-tumor efficacy of each drug combination assessed by the RECIST criteria for all other cancers.
Measured: 56 days
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Sorafenib
Anti-tumor efficacy of each drug combination assessed by the WHO criteria if participant has lymphoma.
Anti-tumor efficacy of each drug combination assessed by the RECIST criteria for all other cancers.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study start19 Aug 2010
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon Westin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187199
- Sponsor's protocol ID
- 2010-0486
- Other IDs
- NCI-2012-01788
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2010
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Subbiah V, Westin SN, Wang K, Araujo D, Wang WL, Miller VA, Ross JS, Stephens PJ, Palmer GA, Ali SM. Targeted therapy by combined inhibition of the RAF and mTOR kinases in malignant spindle cell neoplasm harboring the KIAA1549-BRAF fusion protein. J Hematol Oncol. 2014 Jan 14;7:8. doi: 10.1186/1756-8722-7-8.
PubMed 24422672
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer
- ClinicalTrials.gov ID
- NCT01187199
- Acronym / sponsor ID
- 2010-0486
- Conditions
- Advanced Cancer
- Keywords
- Metastatic cancer, Chemotherapy, Avastin, Carboplatin, Paclitaxel, Sorafenib, Temsirolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Aug 2010 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 23 Aug 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 dose of the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The safety of these drug combinations 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.
Temsirolimus is designed to block the growth of cancer cells, which may eventually cause the cancer cells to die.
Carboplatin is designed to damage the DNA (the genetic material of cells)of cancer cells, which may will eventually cause the cancer cells to die.
Paclitaxel is designed to damage the DNA of cancer cells, which may eventually cause the cancer cells to die.
Sorafenib is designed to block the function of important proteins in cancer cells. These proteins, when active, are in part responsible for the abnormal growth and behavior of cancer cells.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, your doctor will decide which study drugs you will receive based on the disease type and on the drugs you have taken in the past.
Every participant will receive bevacizumab and temsirolimus. The study staff will tell you which of the other 3 drugs (carboplatin, paclitaxel, or sorafenib) you will receive.
Once it is decided which drugs you will receive, you will be assigned to a dose level of the drug combination based on when you join this study. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants on each drug combination will receive the lowest doses. 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 each dose combination is found.
Your dose of study drugs may be lowered later, if you do not tolerate the study drug combination well.
Once the highest tolerated dose is found for each group, up to 10 more participants will be added to each group at that dose level. This is called an extension group.
Study Drug Administration:
Each cycle is about 21 days or 28 days, depending on which study drug combination you receive.If you experience side effects, the start of the next cycle may be delayed. Your doctor will tell you on which dose level you will be assigned.
SORAFENIB ARM:
If you are assigned to take sorafenib, you will take it by mouth 1 or 2 times every day (the study staff will tell you how often to take it). You should take sorafenib on an empty stomach, either 1 hour before a meal or 2 hours after a meal.
On Day 1 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus by vein. 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.
CARBOPLATIN ARM:
If you are assigned to take carboplatin,you will receive it by vein over 1 hour on Day 1 of each cycle.
On Day 1 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus by vein. 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.
PACLITAXEL ARM DOSE LEVELS 1-8:
If you are assigned to take paclitaxel on Dose Levels 1 - 8, you will receive it by vein over 3 hours on Days 1, 8, and 15 of each cycle.
On Day 1 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus by vein. 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.
PACLITAXEL ARM DOSE LEVELS 9 - 13:
If you are assigned to take paclitaxel on Dose Levels 9 - 13, you will receive paclitaxel by vein over 3 hours on Days 1, 8, and 15 of each cycle.
On Days 1 and 15 of each cycle, you will receive bevacizumab by vein. The first infusion is over 90 minutes. The next infusion may be over 60 minutes if the first infusion was well-tolerated. If you tolerate the second infusion well, the third infusion may be over 30 minutes.
On Days 1, 8, 15, and 22 of each cycle, you will receive temsirolimus by vein. 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, 15, and 22 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well.
Study Visits:
During Cycle 1:
- Urine will be collected for routine tests on Day 1.
- You will have a physical exam, including measurement of your weight and vital signs (blood pressure, breathing rate, heart rate, and temperature).
- You will be asked how well you are able to perform the normal activities of daily living (performance status) on Days 1 and 8.
- Blood (about 1 tablespoon) will be drawn for routine tests on Days 1, 8, and 15.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam, including of your weight and vital signs..
- Your performance status will be recorded.
- Blood (about 1 tablespoon) and urine will be collected for routine tests
After Cycle 2, you will have a CT scan or MRI scan to check the status of the disease every 2-3 cycles. After 6 months, this may be performed up to every 4 cycles if the doctor thinks it is in your best interest.
Length of Study:
You may remain on study for as long as the doctor thinks it is in you best interest. You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Bevacizumab, temsirolimus, carboplatin, paclitaxel, and sorafenib are all 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. Carboplatin is FDA approved for the treatment of ovarian cancer or non-small cell lung cancer. Paclitaxel is FDA approved for ovarian, breast cancer, and AIDS-related Kaposi's sarcoma. It is also approved in combination with cisplatin for the treatment of ovarian and non-small cell lung cancer. Sorafenib is FDA approved for the treatment of kidney cancer.
The use of these drugs together is investigational.
Up to 278 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carboplatin Group | Experimental | Drug: Temsirolimus, Drug: Bevacizumab, Drug: CarboplatinCarboplatin: Starting dose AUC 2 by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. |
| Paclitaxel Group | Experimental | Drug: Temsirolimus, Drug: Bevacizumab, Drug: PaclitaxelPaclitaxel: Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. |
| Sorafenib Group | Experimental | Drug: Temsirolimus, Drug: Bevacizumab, Drug: SorafenibSorafenib: Starting dose 200 mg by mouth daily for a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Inclusion: (For all treatment arms)
- 1.1 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.
- 1.2 Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation does not target the only measurable or evaluable disease.
- 1.3 Patients must have measurable or evaluable disease
- 1.4 ECOG performance status </= 2 (Karnofsky >/= 60%, Lansky >/= 50%).
Key exclusion criteria (16 listed)
- Exclusion: (For all treatment arms)
- 4.1 Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
- 4.2 Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
- 4.3 Patients with clinically significant cardiovascular disease: History of CVA within 6 months Myocardial infarction or unstable angina within 6 months Unstable angina pectoris New York Heart Association Class > II
- 4.4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
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 |
|---|---|---|
| TemsirolimusAlso: CCI-779, ToriselStarting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. | Drug | Carboplatin Group, Paclitaxel Group, Sorafenib Group |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGFStarting dose 5 mg/kg given by vein on day 1 of a 21 day cycle. | Drug | Carboplatin Group, Paclitaxel Group, Sorafenib Group |
| PaclitaxelAlso: TaxolStarting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle. | Drug | Paclitaxel Group |
| SorafenibAlso: Nexavar, BAY 43-9006Starting dose 200 mg by mouth daily for a 21 day cycle. | Drug | Sorafenib Group |
| CarboplatinAlso: ParaplatinStarting dose AUC 2 by vein on day 1 of a 21 day cycle. | Drug | Carboplatin Group |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 4 weeks
MTD defined by dose-limiting toxicities (DLTs) that occur during the first four weeks of therapy. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v4.0.
3 secondary outcomes
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Carboplatin
Time frame: 56 days
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Paclitaxel
Time frame: 56 days
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Sorafenib
Time frame: 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Derived from this study: PubMed 24422672Subbiah V, Westin SN, Wang K, Araujo D, Wang WL, Miller VA, Ross JS, Stephens PJ, Palmer GA, Ali SM. Targeted therapy by combined inhibition of the RAF and mTOR kinases in malignant spindle cell neoplasm harboring the KIAA1549-BRAF fusion protein. J Hematol Oncol. 2014 Jan 14;7:8. doi: 10.1186/1756-8722-7-8.
- 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.
Shannon Westin, 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 Temsirolimus, Bevacizumab and Paclitaxel 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 15 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: 4 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 NCT01187199, 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 9 Oct 2026.