Endometrial CancerPhase 1NCT01065662
AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
A Phase 1 study testing temsirolimus and cediranib in people with Endometrial Cancer and Ovarian Cancer, run by Susana M. Campos, MD at 3 sites in United States.
Trial summary
The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Ovarian Cancer, Cervical Cancer
- What is being tested?
- temsirolimus and cediranib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Mar 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic endometrial cancer
- Patients with recurrent ovarian, fallopian and peritoneal cancer
- Patients with recurrent cervical cancer
- Patients may have either measurable or non-measurable disease
- Up to one prior line of chemotherapy in the recurrent setting is allowed. Biologic therapies will be considered as a prior line but hormonal therapies do not count.
- No prior VEGF inhibitor therapy allowed.
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- Toxic side effects related to prior chemotherapy or hormonal therapy must have resolved to less than or equal to grade 1 or to baseline (excluding alopecia), or for peripheral neuropathy to less than or equal to grade 2.
- Subjects may begin AZD2171 and temsirolimus at least 3 weeks after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible.
- 18 years of age or older
- At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown. Eligibility of patients receiving any medication or substances known to affect or with teh potential to affect the activity or PK of AZD2171 will be determined following review of their case by the principal investigator.
- Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible if they otherwise meet eligibility. Subjects with stage I or II cancer treated with curative intent are also eligible with no evidence of recurrent disease.
- No evidence of preexisting uncontrolled hypertension. If patient has hypertension, it must be medically controlled prior to starting AZD2171.
- Women of child-bearing potential must have a negative pregnancy test prior to study entry. Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
- No therapeutic anticoagulation. The use of low dose warfarin, intermittent doses of TPA, or heparin flushes to prophylaxis against central venous catheter-associated clots is permitted.
- ECOG Performance status 0-2
- Patients must have normal organ and marrow function as defined in the protocol
Who cannot join
- Patients who have had chemotherapy, radiotherapy, or major surgery within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks. Prior bevacizumab is allowed.
- Patients may not be receiving any medication that may markedly affect renal function. NSAIDs should be avoided if possible.
- Patients with known brain metastases should be excluded from this clinical trial. A CT of the head is required prior to entry into the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171.
- Mean QTc of 470msec or greater in screening electrocardiogram or history of familial long QT syndrome.
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- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Inability to take and absorb orally administered medication.
- Pregnant women. Breastfeeding should be discontinued.
- Major surgical procedure or medical interference with peritoneum or pleura within 4 weeks of baseline CA-125 assessments. This excludes the need for a paracentesis.
- Subjects with a history of an active malignancy during the last 3 years except non-melanomatous skin cancer, in situ breast or cervical cancer or stage I or II cancer treated with a curative intent and no active cancer recurrence.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171.
- New York Heart Association classification of III or IV
- Conditions requiring concurrent use of drugs or biologics with proarrhythmic potential.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.
Read the detailed description
- We are looking for the highest dose of the study drugs that can be administered safely without severe or unmanageable side effects in participants that have recurrent gynecological cancers. Not everyone who participates in this research study will receive the same dose of the study drug.
- There will be samples of blood taken that measure any additional effect of the study drugs and to look for a marker for the participant's particular type of cancer. Blood will be taken at a certain point in the study to evaluate the interaction of the two study drugs, cediranib and temsirolimus when given together. These are called pharmacokinetic (PK) samples. About 6 teaspoons of blood will be taken with each PK sample with a total of 34 samples taken.
- Participants will be given a study medication diary for each treatment cycle. Each cycle lasts four weeks (28 days). Temsirolimus will be given on days 1, 8, 15 and 22 of each cycle. Cediranib wil be taken orally once daily in the morning.
- Participants will be asked to monitor their blood pressure on a daily basis at home and keep a blood pressure diary.
- The following tests and procedures will be performed at specific time periods during the course of the study: medical history; side effect assessment; physical exam; vital signs; blood tests; CT scan; MUGA or ECHO; EKG and urine test.
- Conditions
- Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- temsirolimus, cediranib
- Keywords
- AZD2171, temsirolimus, advanced gynecological malignancies
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temsirolimusDrug
Given on days 1, 8, 15 and 22 of each cycle
cediranibDrug
Taken orally daily
| Study group | Role | What they receive |
|---|---|---|
| Cediranib and Temsirolimus | Experimental | Please see interventions section. Receives: Drug: temsirolimus; Drug: cediranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of cediranib with temsirolimus in patients with recurrent/refractory gynecological malignancies.
Measured: 1 year
Secondary outcomes (1)
To determine the efficacy of this combination as measured by response rate or clinical benefit.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2013
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susana M. Campos, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, National Comprehensive Cancer Network, Wyeth is now a wholly owned subsidiary of Pfizer, AstraZeneca
- Responsible party
- Sponsor-investigator, Susana M. Campos, MD, Dana-Farber Cancer Institute
- Investigators
- Susana Campos, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065662
- Sponsor's protocol ID
- 09-397
- Status last verified
- Apr 2021
- First submitted
- 8 Feb 2010
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT01065662
- Acronym / sponsor ID
- 09-397
- Conditions
- Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- AZD2171, temsirolimus, advanced gynecological malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Susana M. Campos, MDUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, National Comprehensive Cancer Network, Wyeth is now a wholly owned subsidiary of Pfizer, AstraZeneca
- Study start
- Feb 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 9 Feb 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 purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.
Detailed description
- We are looking for the highest dose of the study drugs that can be administered safely without severe or unmanageable side effects in participants that have recurrent gynecological cancers. Not everyone who participates in this research study will receive the same dose of the study drug.
- There will be samples of blood taken that measure any additional effect of the study drugs and to look for a marker for the participant's particular type of cancer. Blood will be taken at a certain point in the study to evaluate the interaction of the two study drugs, cediranib and temsirolimus when given together. These are called pharmacokinetic (PK) samples. About 6 teaspoons of blood will be taken with each PK sample with a total of 34 samples taken.
- Participants will be given a study medication diary for each treatment cycle. Each cycle lasts four weeks (28 days). Temsirolimus will be given on days 1, 8, 15 and 22 of each cycle. Cediranib wil be taken orally once daily in the morning.
- Participants will be asked to monitor their blood pressure on a daily basis at home and keep a blood pressure diary.
- The following tests and procedures will be performed at specific time periods during the course of the study: medical history; side effect assessment; physical exam; vital signs; blood tests; CT scan; MUGA or ECHO; EKG and urine test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cediranib and Temsirolimus | Experimental | Drug: temsirolimus, Drug: cediranibPlease see interventions section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with metastatic endometrial cancer
- Patients with recurrent ovarian, fallopian and peritoneal cancer
- Patients with recurrent cervical cancer
- Patients may have either measurable or non-measurable disease
- Up to one prior line of chemotherapy in the recurrent setting is allowed. Biologic therapies will be considered as a prior line but hormonal therapies do not count.
Key exclusion criteria (15 listed)
- Patients who have had chemotherapy, radiotherapy, or major surgery within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks. Prior bevacizumab is allowed.
- Patients may not be receiving any medication that may markedly affect renal function. NSAIDs should be avoided if possible.
- Patients with known brain metastases should be excluded from this clinical trial. A CT of the head is required prior to entry into the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171.
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 |
|---|---|---|
| temsirolimusGiven on days 1, 8, 15 and 22 of each cycle | Drug | Cediranib and Temsirolimus |
| cediranibTaken orally daily | Drug | Cediranib and Temsirolimus |
Primary outcome
To determine the maximum tolerated dose of cediranib with temsirolimus in patients with recurrent/refractory gynecological malignancies.
Time frame: 1 year
1 secondary outcome
To determine the efficacy of this combination as measured by response rate or clinical benefit.
Time frame: 2 years
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 21 Apr 2021.
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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.
Susana Campos, MD principal investigator
Dana-Farber Cancer Institute
3 sites 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 and cediranib in people with Endometrial Cancer and Ovarian Cancer, run by Susana M. Campos, MD at 3 sites 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 16 inclusion and 15 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To determine the maximum tolerated dose of cediranib with temsirolimus in patients with recurrent/refractory gynecological malignancies. (time frame: 1 year). 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 21 Apr 2021.