Advanced CancerPhase 1NCT00770731
Study of Temsirolimus, Topotecan, and Bortezomib
A Phase 1 study testing Torisel (Temsirolimus), Hycamtin (Topotecan) and Velcade (Bortezomib) 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 Torisel (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Torisel (Temsirolimus), Hycamtin (Topotecan) and Velcade (Bortezomib)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2012
- 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 improves survival by at least three months
- Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, and antibody or other biological therapy, whichever is shorter.
- Patients should be at least four weeks from the last day of therapeutic radiation.
- The Eastern Cooperative Oncology Group (ECOG) performance status </= 2 or Karnofsky >/= 60%.
- Patients must have allowable organ and marrow function defined as: Absolute neutrophil count >/= 1,000/mL, Platelets >/=75,000/mL, Serum creatinine </= 2 * Upper Limit of Normal (ULN), Total bilirubin </= 2 * ULN, aminotransferase (ALT or SGPT) </= 3 * ULN, Fasting total cholesterol <= 350 mg/dL and triglyceride level <= 400 mg/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 and for the duration of study participation, and will be advised to avoid pregnancy for 3 months after completion of therapy.
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- 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 except for continuing on hormonal therapy in cases of prostate cancer.
- Treatment on this study may begin within 24 hours after Phase 0 dose of temsirolimus.
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.
- Patients with clinically significant cardiovascular disease: • History of CVA within 6 months • Myocardial infarction or unstable angina within 6 months • Unstable angina pectoris
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- Pregnant or lactating women.
- History of hypersensitivity to bortezomib or any component of the bortezomib formulation.
- History of hypersensitivity to topotecan or any component of the topotecan formulation.
- History of hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy
The goal of this clinical research study is to find the highest tolerable dose of Torisel (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) 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:
Temsirolimus is designed to block pathways that control important events such as the growth of blood vessels that are vital for the growth of cancer. This may cause cancer cells to die.
Topotecan hydrochloride is designed to block the function of important proteins in cancer cells. These proteins, when active, allow a cell's genes to duplicate and for the cancer cells to divide.
Bortezomib is designed to block the function of important proteins in cancer cells. These proteins control the destruction of proteins in tumor cells, which is important for their growth. This may cause cancer cells to die.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be enrolled into a group of about 3-6 participants that are receiving the same drug combination. The first group of participants will receive the lowest dose of the drug combination. The next group of participants will receive the next highest dose of the drug combination. The third group will receive an even higher dose than that. This process will continue until the study doctor finds the highest safe dose of the drug combination. The dose that you receive will depend on when you are enrolled in this study and the safety data that is available at that time. The dose that you receive may be lowered if you do not tolerate the study drug combination well. You will not receive any doses of the study drug higher than the dose you are first assigned to.
Once the highest tolerated dose is found, up to 10 more participants will be added at that dose level. This is called an Expansion Group.
Study Drug Administration:
Temsirolimus, topotecan, and bortezomib will be given in "cycles." Cycles will be about 21 days long or longer, depending on any side effects you may experience.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus through a needle in your vein over about 30-60 minutes.
On Days 1 and 8 of each cycle, you will receive topotecan hydrochloride by vein over about 30-60 minutes.
On Days 1, 4, 8, and 11 of each cycle, you will receive bortezomib by vein over less than 1 minute.
While on study you will not be able to take any drugs that may interfere with the study drugs. You should talk with your doctor before taking any non-study drugs.
Study Visits:
Once a week during Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, urine will be collected for routine tests.
If you are in the Expansion Group, then during Week 3 of Cycle 1, you will have a tumor biopsy to compare the activity of the tumor before treatment and after treatment has begun. This is done for research purposes only.
If you are in the Expansion Group, then 24-48 hours after starting Week 1 of Cycle 1, you will have a bone marrow aspiration performed. The tissue will be used to see how the study drug combination acts in the body and to learn the effect it may have on cancer cells. This is done for research purposes only.
During Week 1 of Cycle 2, you will have an ECG. After this, you will have extra ECGs if the doctor thinks it is needed.
During Week 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, urine may be collected for routine tests.
Once every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease.
FDG-PET Scans:
Every 2-3 months while you are on study and before Cycle 1 if you have not had a FDG-PET within the last 1 month, you may have a FDG-PET scan. You must fast for at least 6 hours before the FDG-PET scan. If you are a diabetic, you must fast for at least 4 hours before the FDG-PET scan. If it is needed, you may take drugs or drink water. The FDG-PET will be used to see if the activity of the cancers decreased with the drugs.
You will receive a small amount of FDG solution by vein. You will then rest in a quiet darkened room for 45-60 minutes before the PET scan. Pictures of your body will be taken using a PET scanner, which will about take 1 1/2 hours. The entire procedure should take about 3 hours.
Each time you have a FDG-PET scan, blood (either a finger stick or about 1 teaspoon) will be drawn to measure your blood sugar levels.
Length of Study Participation:
You will be on study for as long as you are benefiting. You will be taken off study if the disease gets worse or intolerable side effects occur.
End-of-Treatment Visit:
After you are off study, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
This is an investigational study. Temsirolimus, topotecan, and bortezomib are all FDA approved and commercially available. Temsirolimus is FDA approved for the treatment of renal cell cancer. Topotecan hydrochloride is FDA approved for the treatment of ovarian, small cell lung, and cervical cancers. Bortezomib is FDA approved for the treatment of multiple myeloma and mantle cell lymphoma. The use of these drugs together is investigational and authorized for use in research only.
Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Torisel (Temsirolimus), Hycamtin (Topotecan), Velcade (Bortezomib)
- Keywords
- Torisel, Temsirolimus, Hycamtin, Topotecan hydrochloride, Velcade, Bortezomib, FDG-PET Scans, 18F-Fluoro-2-Deoxyglucose Positron Emission Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torisel (Temsirolimus)Drug
Also called Temsirolimus, CCI-779
Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle
Hycamtin (Topotecan)Drug
Also called Topotecan, Topotecan Hydrochloride
Starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle
Velcade (Bortezomib)Drug
Also called Bortezomib, LDP-341, MLN341, PS-341
Starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle
| Study group | Role | What they receive |
|---|---|---|
| Torisel + Hycamtin + Velcade | Experimental | Torisel starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle.
Hycamtin starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle.
Velcade starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle. Receives: Drug: Torisel (Temsirolimus); Drug: Hycamtin (Topotecan); Drug: Velcade (Bortezomib) |
| Expansion Group | Experimental | Torisel + Hycamtin + Velcade Expansion Group
Addition of 10 participants at highest tolerated dose level Receives: Drug: Torisel (Temsirolimus); Drug: Hycamtin (Topotecan); Drug: Velcade (Bortezomib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of combination treatment with temsirolimus, topotecan, and bortezomib
MTD is defined as the highest dose in which the incidence of a dose limiting toxicity (DLT) is < 33%.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2012
- Study completionNov 2012
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Karp, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770731
- Sponsor's protocol ID
- 2008-0425
- Status last verified
- Feb 2013
- First submitted
- 9 Oct 2008
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT00770731
- Acronym / sponsor ID
- 2008-0425
- Conditions
- Advanced Cancer
- Keywords
- Torisel, Temsirolimus, Hycamtin, Topotecan hydrochloride, Velcade, Bortezomib, FDG-PET Scans, 18F-Fluoro-2-Deoxyglucose Positron Emission Tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Oct 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 Torisel (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) 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:
Temsirolimus is designed to block pathways that control important events such as the growth of blood vessels that are vital for the growth of cancer. This may cause cancer cells to die.
Topotecan hydrochloride is designed to block the function of important proteins in cancer cells. These proteins, when active, allow a cell's genes to duplicate and for the cancer cells to divide.
Bortezomib is designed to block the function of important proteins in cancer cells. These proteins control the destruction of proteins in tumor cells, which is important for their growth. This may cause cancer cells to die.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be enrolled into a group of about 3-6 participants that are receiving the same drug combination. The first group of participants will receive the lowest dose of the drug combination. The next group of participants will receive the next highest dose of the drug combination. The third group will receive an even higher dose than that. This process will continue until the study doctor finds the highest safe dose of the drug combination. The dose that you receive will depend on when you are enrolled in this study and the safety data that is available at that time. The dose that you receive may be lowered if you do not tolerate the study drug combination well. You will not receive any doses of the study drug higher than the dose you are first assigned to.
Once the highest tolerated dose is found, up to 10 more participants will be added at that dose level. This is called an Expansion Group.
Study Drug Administration:
Temsirolimus, topotecan, and bortezomib will be given in "cycles." Cycles will be about 21 days long or longer, depending on any side effects you may experience.
On Days 1, 8, and 15 of each cycle, you will receive temsirolimus through a needle in your vein over about 30-60 minutes.
On Days 1 and 8 of each cycle, you will receive topotecan hydrochloride by vein over about 30-60 minutes.
On Days 1, 4, 8, and 11 of each cycle, you will receive bortezomib by vein over less than 1 minute.
While on study you will not be able to take any drugs that may interfere with the study drugs. You should talk with your doctor before taking any non-study drugs.
Study Visits:
Once a week during Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, urine will be collected for routine tests.
If you are in the Expansion Group, then during Week 3 of Cycle 1, you will have a tumor biopsy to compare the activity of the tumor before treatment and after treatment has begun. This is done for research purposes only.
If you are in the Expansion Group, then 24-48 hours after starting Week 1 of Cycle 1, you will have a bone marrow aspiration performed. The tissue will be used to see how the study drug combination acts in the body and to learn the effect it may have on cancer cells. This is done for research purposes only.
During Week 1 of Cycle 2, you will have an ECG. After this, you will have extra ECGs if the doctor thinks it is needed.
During Week 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, urine may be collected for routine tests.
Once every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease.
FDG-PET Scans:
Every 2-3 months while you are on study and before Cycle 1 if you have not had a FDG-PET within the last 1 month, you may have a FDG-PET scan. You must fast for at least 6 hours before the FDG-PET scan. If you are a diabetic, you must fast for at least 4 hours before the FDG-PET scan. If it is needed, you may take drugs or drink water. The FDG-PET will be used to see if the activity of the cancers decreased with the drugs.
You will receive a small amount of FDG solution by vein. You will then rest in a quiet darkened room for 45-60 minutes before the PET scan. Pictures of your body will be taken using a PET scanner, which will about take 1 1/2 hours. The entire procedure should take about 3 hours.
Each time you have a FDG-PET scan, blood (either a finger stick or about 1 teaspoon) will be drawn to measure your blood sugar levels.
Length of Study Participation:
You will be on study for as long as you are benefiting. You will be taken off study if the disease gets worse or intolerable side effects occur.
End-of-Treatment Visit:
After you are off study, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
This is an investigational study. Temsirolimus, topotecan, and bortezomib are all FDA approved and commercially available. Temsirolimus is FDA approved for the treatment of renal cell cancer. Topotecan hydrochloride is FDA approved for the treatment of ovarian, small cell lung, and cervical cancers. Bortezomib is FDA approved for the treatment of multiple myeloma and mantle cell lymphoma. The use of these drugs together is investigational and authorized for use in research only.
Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Torisel + Hycamtin + Velcade | Experimental | Drug: Torisel (Temsirolimus), Drug: Hycamtin (Topotecan), Drug: Velcade (Bortezomib)Torisel starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle. Hycamtin starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle. Velcade starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle. |
| Expansion Group | Experimental | Drug: Torisel (Temsirolimus), Drug: Hycamtin (Topotecan), Drug: Velcade (Bortezomib)Torisel + Hycamtin + Velcade Expansion Group Addition of 10 participants at highest tolerated dose level |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months
- Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, and antibody or other biological therapy, whichever is shorter.
- Patients should be at least four weeks from the last day of therapeutic radiation.
- The Eastern Cooperative Oncology Group (ECOG) performance status </= 2 or Karnofsky >/= 60%.
- Patients must have allowable organ and marrow function defined as: Absolute neutrophil count >/= 1,000/mL, Platelets >/=75,000/mL, Serum creatinine </= 2 * Upper Limit of Normal (ULN), Total bilirubin </= 2 * ULN, aminotransferase (ALT or SGPT) </= 3 * ULN, Fasting total cholesterol <= 350 mg/dL and triglyceride level <= 400 mg/dL.
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.
- Patients with clinically significant cardiovascular disease: • History of CVA within 6 months • Myocardial infarction or unstable angina within 6 months • Unstable angina pectoris
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- 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 |
|---|---|---|
| Torisel (Temsirolimus)Also: Temsirolimus, CCI-779Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle | Drug | Expansion Group, Torisel + Hycamtin + Velcade |
| Hycamtin (Topotecan)Also: Topotecan, Topotecan HydrochlorideStarting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle | Drug | Expansion Group, Torisel + Hycamtin + Velcade |
| Velcade (Bortezomib)Also: Bortezomib, LDP-341, MLN341, PS-341Starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle | Drug | Expansion Group, Torisel + Hycamtin + Velcade |
Primary outcome
Maximum Tolerated Dose (MTD) of combination treatment with temsirolimus, topotecan, and bortezomib
Time frame: 21 days
MTD is defined as the highest dose in which the incidence of a dose limiting toxicity (DLT) is < 33%.
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 13 Feb 2013.
- UT MD Anderson Cancer CenterLink 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.
Daniel Karp, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Torisel (Temsirolimus), Hycamtin (Topotecan) and Velcade (Bortezomib) 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 9 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 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of combination treatment with temsirolimus, topotecan, and bortezomib (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 13 Feb 2013.