Solid TumorsPhase 1NCT01197170
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
A Phase 1 study testing Anastrozole, Bevacizumab and Everolimus in people with Solid Tumors and Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Advanced Cancer
- What is being tested?
- Anastrozole, Bevacizumab and Everolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2010to 13 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
- Measurable or non-measurable disease
- Patients must have tumors that demonstrate ER/PR+ (positivity by IHC staining >/= 1%).
- At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (Exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 5 X ULN.
Show all 9Show fewer
- Women of childbearing 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 30 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document
- Female patients must either be: Post-menopausal women as defined by a. age >/= 60 years of age; b. prior bilateral oophorectomy; c. age < 60 with at least 12 months of spontaneous amenorrhea or post-menopausal range FSH and estradiol levels OR Premenopausal women receiving a gonadotropin-releasing hormone agonist.
Who cannot join
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
- Women who are pregnant or breastfeeding
- Patients with a history of bone marrow transplant within the previous two years.
- Patients with a known hypersensitivity to any of the components of the drug products.
Show all 9Show fewer
- Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- Patients with major surgery within 30 days prior to entering the study.
- Age under 18 years.
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 to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.
Read the detailed description
The Study Drugs:
Anastrozole is designed to block the last step in estrogen (a hormone) production. In estrogen-dependent tumors, anastrozole may block tumor growth.
Sorafenib is designed to block the function of a cancer protein as well as tumor blood-vessel forming proteins. It may stop the growth of blood vessels in tumors.
Bevacizumab is designed to block or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients for tumor growth.
Everolimus is designed to block cancer proteins and may block tumor growth.
Erlotinib 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.
Fulvestrant is designed to block estrogen action. In estrogen-dependent tumors, fulvestrant may block tumor growth.
Study Drug Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group. The study staff will tell you the group you will be in.
Anastrozole Alone:
If you have not received earlier hormonal treatment, you may receive anastrozole alone.
Anastrozole Combination Groups:
If you have benefitted from hormonal treatment in the past, you may receive anastrozole combined with either bevacizumab, everolimus, sorafenib, or erlotinib.
If you are receiving treatment with a combination of drugs, you will be assigned to a dose level based on when you joined the study. Every group will receive the same dose level of anastrozole. The first group of participants will receive the lowest dose level of the second study drug (bevacizumab, everolimus, sorafenib, or erlotinib). Each new group will receive a higher dose of the second study drug than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the drug combinations are found.
Once the highest tolerated dose of the drug combinations are found, 10 extra participants will be enrolled at this dose level for each combination. This is called the expansion group.
In addition to this expansion, if a particular tumor type has responded to the study drug(s), 14 more participants with that tumor type will be enrolled at the highest safe dose level that has been found.
If your tumor starts growing again after an initial response to the combination of 2 drugs, a third drug may be added to the combination you have been taking. Depending on your current treatment one of the following drugs may be added: bevacizumab, everolimus, sorafenib, fulvestrant, or erlotinib.
Study Drug Administration:
If you take anastrozole alone or in combination with sorafenib or erlotinib or everolimus, each study "cycle" is 28 days. If you take anastrozole in combination with bevacizumab, each study "cycle" is 21 days.
You will take anastrozole by mouth 1 time every day. You can take this with or without food.
If you are assigned to take sorafenib, you will take it by mouth 1 or 2 times every day. Your doctor will tell you how often to take sorafenib. You should take sorafenib on an empty stomach either 1 hour before a meal or 2 hours after a meal.
If you are assigned to take bevacizumab, you will receive it by vein on Day 1 of every cycle. During Day 1 of Cycle 1, you will receive it over 90 minutes. The infusion time may be lowered if you tolerate the drug well.
If you are assigned to take everolimus, you will take it by mouth 1 time every day with food.
If you are assigned to take erlotinib, you will take it by mouth 1 time every day. You should take erlotinib on an empty stomach either 1 hour before eating or 2 hours after eating.
If you are assigned to receive fulvestrant, you will receive injections about one time every month. Depending on your study drug combination, you may receive 2 injections in the first month.
For the first Cycle of any of the assigned combinations you will receive the medication at MD Anderson. After the first cycle you may receive the medication with your home physician if your study doctor feels it is safe.
Study Visits:
At every visit, you will be asked if you have had any side effects.
If you take anastrozole combinations in a 28 day cycle, you will have the following tests and procedures:
During Weeks 1 and 3 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
During Week 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If your study doctor feels it is safe, you may have these follow-up visits with your home physician.
Every 3 cycles, you will have a CT scan, MRI scan, PET scan, and/or PET/CT scan to check the status of the disease. If the study doctor thinks more scans are needed, they will be performed more often.
If you take anastrozole combinations in a 21 day cycle, you will have the following tests and procedures:
During Week 1 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
During Week 1 of Cycle 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If your study doctor feels it is safe, you may have these follow-up visits with your home physician.
Every 3 cycles, you will have a CT scan, MRI scan, PET scan, and/or PET/CT scan to check the status of the disease. If the study doctor thinks more scans are needed, they will be performed more often.
Length of Study:
You may take the study drug(s) for as long as the doctor thinks it is in your best interest. You will be taken off study if you have intolerable side effects or the cancer gets worse.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 30 days after the last dose of study drug(s), you will have an end-of-study visit. At this visit, the following tests or procedures may be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If the doctor thinks it is needed, you will have a CT scan, MRI scan, PET scan, and/or PET/CT to check the status of the disease.
If you have a serious side effect that lasts after the End-of-Study visit, you will be followed as long as the doctor thinks it is in your best interest.
This is an investigational study. Anastrozole, bevacizumab, everolimus, erlotinib, and sorafenib are all commercially available. Anastrozole is FDA approved to treat postmenopausal women with hormone receptor-positive early breast cancer. Bevacizumab is FDA approved to treat non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, and glioblastoma. Everolimus is FDA approved to treat advanced renal cell carcinoma. Sorafenib is FDA approved to treat advanced renal cell carcinoma, as well as hepatocellular carcinoma that cannot be removed by surgery. Erlotinib is FDA approved to treat NSCLC and pancreatic cancer. Fulvestrant is approved to treat breast cancer in postmenopausal women with estrogen receptor positive cancer.
The combination of these drugs is considered investigational.
Up to 281 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Solid Tumors, Advanced Cancer
- Being tested
- Anastrozole, Bevacizumab, Everolimus, Sorafenib, Erlotinib
- Keywords
- Hormonal therapies, Estrogen receptor, Progesterone receptor, Hormone blockade, Hormone-positive tumors, Advanced cancer, Metastatic cancer, Avastin, Anti-VEGF monoclonal antibody, rhuMAB-VEGF, Afinitor, RAD001, Nexavar, BAY43-9006, OSI-774, Tarceva
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex
1 mg by mouth daily of a 28 day cycle.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAB-VEGF
Starting dose 10 mg by vein on day 1 of a 21 day cycle.
EverolimusDrug
Also called Afinitor, RAD001
Starting dose 5 mg by mouth daily for a 28 day cycle.
SorafenibDrug
Also called Nexavar, BAY43-9006
Starting dose 200 mg by mouth twice a day of a 28 day cycle.
ErlotinibDrug
Also called OSI-774, Tarceva
Starting dose 75 mg by mouth daily for a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole | Experimental | 1 mg PO (by mouth) daily for 28 days. Receives: Drug: Anastrozole |
| Anastrozole + Bevacizumab | Experimental | Anastrozole 1 mg PO daily and Bevacizumab starting dose 10 mg IV Day 1 of 21 day cycle. Expansion group added when MTD dose of Anastrozole + Bevacizumab found. Receives: Drug: Anastrozole; Drug: Bevacizumab |
| Anastrozole + Everolimus | Experimental | Anastrozole 1 mg PO daily and Everolimus starting dose 5 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Everolimus found. Receives: Drug: Anastrozole; Drug: Everolimus |
| Anastrozole + Sorafenib | Experimental | Anastrozole 1 mg PO daily and Sorafenib starting dose 200 mg PO twice a day for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Sorafenib found. Receives: Drug: Anastrozole; Drug: Sorafenib |
| Anastrozole + Erlotinib | Experimental | Anastrozole 1 mg PO daily and Erlotinib starting dose 75 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Erlotinib found. Receives: Drug: Anastrozole; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD defined as highest dose at which no more than 1 of 6 evaluable patients has had a dose limiting toxicity (DLT). Six patients should be treated before the dose is declared as MTD. DLTs defined as adverse events (AEs) related to study agents which occurs during the first cycle of treatment.
Measured: 28 day cycle
Secondary outcomes (1)
Tumor Response
Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a ≥ 25% decrease in CA125 for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in the tumor density, as measured in Hounsfield units (HU), by more than or equal to 15%.
Measured: Every 21 or 28 days depending on study group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study start7 Sep 2010
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
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 Solid TumorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Janku, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197170
- Sponsor's protocol ID
- 2010-0504
- Other IDs
- NCI-2012-01794
- Status last verified
- Jan 2021
- First submitted
- 7 Sep 2010
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wheler JJ, Moulder SL, Naing A, Janku F, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Stephens PJ, Kurzrock R. Anastrozole and everolimus in advanced gynecologic and breast malignancies: activity and molecular alterations in the PI3K/AKT/mTOR pathway. Oncotarget. 2014 May 30;5(10):3029-38. doi: 10.18632/oncotarget.1799.
PubMed 24912489
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
- ClinicalTrials.gov ID
- NCT01197170
- Acronym / sponsor ID
- 2010-0504
- Conditions
- Solid Tumors, Advanced Cancer
- Keywords
- Hormonal therapies, Estrogen receptor, Progesterone receptor, Hormone blockade, Hormone-positive tumors, Advanced cancer, Metastatic cancer, Avastin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 7 Sep 2010 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 9 Sep 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 to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.
Detailed description
The Study Drugs:
Anastrozole is designed to block the last step in estrogen (a hormone) production. In estrogen-dependent tumors, anastrozole may block tumor growth.
Sorafenib is designed to block the function of a cancer protein as well as tumor blood-vessel forming proteins. It may stop the growth of blood vessels in tumors.
Bevacizumab is designed to block or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients for tumor growth.
Everolimus is designed to block cancer proteins and may block tumor growth.
Erlotinib 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.
Fulvestrant is designed to block estrogen action. In estrogen-dependent tumors, fulvestrant may block tumor growth.
Study Drug Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group. The study staff will tell you the group you will be in.
Anastrozole Alone:
If you have not received earlier hormonal treatment, you may receive anastrozole alone.
Anastrozole Combination Groups:
If you have benefitted from hormonal treatment in the past, you may receive anastrozole combined with either bevacizumab, everolimus, sorafenib, or erlotinib.
If you are receiving treatment with a combination of drugs, you will be assigned to a dose level based on when you joined the study. Every group will receive the same dose level of anastrozole. The first group of participants will receive the lowest dose level of the second study drug (bevacizumab, everolimus, sorafenib, or erlotinib). Each new group will receive a higher dose of the second study drug than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the drug combinations are found.
Once the highest tolerated dose of the drug combinations are found, 10 extra participants will be enrolled at this dose level for each combination. This is called the expansion group.
In addition to this expansion, if a particular tumor type has responded to the study drug(s), 14 more participants with that tumor type will be enrolled at the highest safe dose level that has been found.
If your tumor starts growing again after an initial response to the combination of 2 drugs, a third drug may be added to the combination you have been taking. Depending on your current treatment one of the following drugs may be added: bevacizumab, everolimus, sorafenib, fulvestrant, or erlotinib.
Study Drug Administration:
If you take anastrozole alone or in combination with sorafenib or erlotinib or everolimus, each study "cycle" is 28 days. If you take anastrozole in combination with bevacizumab, each study "cycle" is 21 days.
You will take anastrozole by mouth 1 time every day. You can take this with or without food.
If you are assigned to take sorafenib, you will take it by mouth 1 or 2 times every day. Your doctor will tell you how often to take sorafenib. You should take sorafenib on an empty stomach either 1 hour before a meal or 2 hours after a meal.
If you are assigned to take bevacizumab, you will receive it by vein on Day 1 of every cycle. During Day 1 of Cycle 1, you will receive it over 90 minutes. The infusion time may be lowered if you tolerate the drug well.
If you are assigned to take everolimus, you will take it by mouth 1 time every day with food.
If you are assigned to take erlotinib, you will take it by mouth 1 time every day. You should take erlotinib on an empty stomach either 1 hour before eating or 2 hours after eating.
If you are assigned to receive fulvestrant, you will receive injections about one time every month. Depending on your study drug combination, you may receive 2 injections in the first month.
For the first Cycle of any of the assigned combinations you will receive the medication at MD Anderson. After the first cycle you may receive the medication with your home physician if your study doctor feels it is safe.
Study Visits:
At every visit, you will be asked if you have had any side effects.
If you take anastrozole combinations in a 28 day cycle, you will have the following tests and procedures:
During Weeks 1 and 3 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
During Week 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If your study doctor feels it is safe, you may have these follow-up visits with your home physician.
Every 3 cycles, you will have a CT scan, MRI scan, PET scan, and/or PET/CT scan to check the status of the disease. If the study doctor thinks more scans are needed, they will be performed more often.
If you take anastrozole combinations in a 21 day cycle, you will have the following tests and procedures:
During Week 1 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
During Week 1 of Cycle 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If your study doctor feels it is safe, you may have these follow-up visits with your home physician.
Every 3 cycles, you will have a CT scan, MRI scan, PET scan, and/or PET/CT scan to check the status of the disease. If the study doctor thinks more scans are needed, they will be performed more often.
Length of Study:
You may take the study drug(s) for as long as the doctor thinks it is in your best interest. You will be taken off study if you have intolerable side effects or the cancer gets worse.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 30 days after the last dose of study drug(s), you will have an end-of-study visit. At this visit, the following tests or procedures may be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If the doctor thinks it is needed, you will have a CT scan, MRI scan, PET scan, and/or PET/CT to check the status of the disease.
If you have a serious side effect that lasts after the End-of-Study visit, you will be followed as long as the doctor thinks it is in your best interest.
This is an investigational study. Anastrozole, bevacizumab, everolimus, erlotinib, and sorafenib are all commercially available. Anastrozole is FDA approved to treat postmenopausal women with hormone receptor-positive early breast cancer. Bevacizumab is FDA approved to treat non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, and glioblastoma. Everolimus is FDA approved to treat advanced renal cell carcinoma. Sorafenib is FDA approved to treat advanced renal cell carcinoma, as well as hepatocellular carcinoma that cannot be removed by surgery. Erlotinib is FDA approved to treat NSCLC and pancreatic cancer. Fulvestrant is approved to treat breast cancer in postmenopausal women with estrogen receptor positive cancer.
The combination of these drugs is considered investigational.
Up to 281 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anastrozole | Experimental | Drug: Anastrozole1 mg PO (by mouth) daily for 28 days. |
| Anastrozole + Bevacizumab | Experimental | Drug: Anastrozole, Drug: BevacizumabAnastrozole 1 mg PO daily and Bevacizumab starting dose 10 mg IV Day 1 of 21 day cycle. Expansion group added when MTD dose of Anastrozole + Bevacizumab found. |
| Anastrozole + Everolimus | Experimental | Drug: Anastrozole, Drug: EverolimusAnastrozole 1 mg PO daily and Everolimus starting dose 5 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Everolimus found. |
| Anastrozole + Sorafenib | Experimental | Drug: Anastrozole, Drug: SorafenibAnastrozole 1 mg PO daily and Sorafenib starting dose 200 mg PO twice a day for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Sorafenib found. |
| Anastrozole + Erlotinib | Experimental | Drug: Anastrozole, Drug: ErlotinibAnastrozole 1 mg PO daily and Erlotinib starting dose 75 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Erlotinib found. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
- Measurable or non-measurable disease
- Patients must have tumors that demonstrate ER/PR+ (positivity by IHC staining >/= 1%).
- At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (Exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
Key exclusion criteria (9 listed)
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
- Women who are pregnant or breastfeeding
- Patients with a history of bone marrow transplant within the previous two years.
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 |
|---|---|---|
| AnastrozoleAlso: Arimidex1 mg by mouth daily of a 28 day cycle. | Drug | Anastrozole, Anastrozole + Bevacizumab, Anastrozole + Erlotinib, Anastrozole + Everolimus, Anastrozole + Sorafenib |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAB-VEGFStarting dose 10 mg by vein on day 1 of a 21 day cycle. | Drug | Anastrozole + Bevacizumab |
| EverolimusAlso: Afinitor, RAD001Starting dose 5 mg by mouth daily for a 28 day cycle. | Drug | Anastrozole + Everolimus |
| SorafenibAlso: Nexavar, BAY43-9006Starting dose 200 mg by mouth twice a day of a 28 day cycle. | Drug | Anastrozole + Sorafenib |
| ErlotinibAlso: OSI-774, TarcevaStarting dose 75 mg by mouth daily for a 28 day cycle. | Drug | Anastrozole + Erlotinib |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 day cycle
MTD defined as highest dose at which no more than 1 of 6 evaluable patients has had a dose limiting toxicity (DLT). Six patients should be treated before the dose is declared as MTD. DLTs defined as adverse events (AEs) related to study agents which occurs during the first cycle of treatment.
1 secondary outcome
Tumor Response
Time frame: Every 21 or 28 days depending on study group
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 22 Jan 2021.
- Derived from this study: PubMed 24912489Wheler JJ, Moulder SL, Naing A, Janku F, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Stephens PJ, Kurzrock R. Anastrozole and everolimus in advanced gynecologic and breast malignancies: activity and molecular alterations in the PI3K/AKT/mTOR pathway. Oncotarget. 2014 May 30;5(10):3029-38. doi: 10.18632/oncotarget.1799.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Solid Tumors
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
Active, not recruitingPhase 1
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Solid Tumors
RecruitingObservational study
Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Malignant Solid Tumors, Other Neoplasms Solid Tumors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
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.
Filip Janku, MD, PHD 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 Anastrozole, Bevacizumab and Everolimus in people with Solid Tumors and 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 9 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 22 Jan 2021. 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: 28 day cycle). 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 NCT01197170, 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 22 Jan 2021.