Breast CancerPhase 1NCT00659568
Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma
A Phase 1 study testing metformin hydrochloride and temsirolimus in people with Breast Cancer and Endometrial Cancer, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Endometrial Cancer, Kidney Cancer
- What is being tested?
- metformin hydrochloride and temsirolimus
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Aug 2010
- 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
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- AST ≤ 2.5 times upper limit of normal (ULN)
- Serum creatinine ≤ ULN
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- Serum bilirubin ≤ 1.5 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to understand and willing to sign a written informed consent document
- Recovered from all prior therapy
- At least 4 weeks since prior chemotherapy or radiotherapy (6 weeks for carmustine or mitomycin C) except low-dose, non-myelosuppressive radiotherapy
- No limitation on other prior therapy
- Concurrent low-dose anticoagulant (i.e., warfarin) allowed provided INR ≤ 1.1 times ULN
- Concurrent full-dose anticoagulant (i.e., warfarin) allowed provided INR is within institutional therapeutic range (usually 2.0-3.0)
Who cannot join
- Allergies to or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to temsirolimus or metformin
- Diabetes mellitus (type I or II)
- Uncontrolled hypertriglyceridemia (triglyceride levels > 10 mmol/L)
- History of lactic acidosis
- Inability to swallow or digest oral medications
- Uncontrolled intercurrent illness including, but not limited to, any of the following:
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- Uncontrolled hypertension
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
- Significant traumatic injury within 21 days prior to treatment
- PRIOR CONCURRENT THERAPY:
- Major surgery within the past 21 days
- Prior temsirolimus (or other known inhibitors of mammalian target of rapamycin) or metformin
- Concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, or phenobarbital) or other CYP3A4 inducer (e.g., rifampin or Hypericum perforatum [St. John's wort])
- Concurrent investigational or commercial agents or therapies to treat the patient's malignancy
- Other concurrent investigational agents other than temsirolimus or metformin
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6
About this study
Official title: A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma.
Secondary
- To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients.
- To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
- Conditions
- Breast Cancer, Endometrial Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- metformin hydrochloride, temsirolimus
- Keywords
- unspecified adult solid tumor, protocol specific, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent small cell lung cancer, extensive stage small cell lung cancer, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Kidney Neoplasms, Lung Neoplasms, Lymphoma, Carcinoma, Renal Cell, Small Cell Lung Carcinoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin hydrochlorideDrug
temsirolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
Secondary outcomes (5)
Toxicity and safety, with particular reference to glucose and lipid deregulation
Antitumor activity, including tumor response rate and time to progression
Objective response
Survival
Frequency and severity of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Mary Mackenzie, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659568
- Sponsor's protocol ID
- CAN-LRCC-UWOREB13877
- Other IDs
- CDR0000593360, WYETH-CAN-LRCC-UWOREB13877
- Status last verified
- Aug 2010
- First submitted
- 15 Apr 2008
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00659568
- Acronym / sponsor ID
- CAN-LRCC-UWOREB13877
- Conditions
- Breast Cancer, Endometrial Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2010
- First posted
- 16 Apr 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.
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
Detailed description
OBJECTIVES:
Primary
- To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma.
Secondary
- To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients.
- To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- AST ≤ 2.5 times upper limit of normal (ULN)
Key exclusion criteria (20 listed)
- Allergies to or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to temsirolimus or metformin
- Diabetes mellitus (type I or II)
- Uncontrolled hypertriglyceridemia (triglyceride levels > 10 mmol/L)
- History of lactic acidosis
- Inability to swallow or digest oral medications
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 |
|---|---|---|
| metformin hydrochloride | Drug | – |
| temsirolimus | Drug | – |
Primary outcome
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
5 secondary outcomes
Toxicity and safety, with particular reference to glucose and lipid deregulation
Antitumor activity, including tumor response rate and time to progression
Objective response
Survival
Frequency and severity of adverse events
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 30 May 2013.
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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.
Mary Mackenzie, MD principal investigator
London Health Sciences Centre
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 metformin hydrochloride and temsirolimus in people with Breast Cancer and Endometrial Cancer, run by London Health Sciences Centre at 1 site in Canada.
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 20 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 30 May 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 Canada. 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 and recommended phase II dose of metformin hydrochloride when administered with temsirolimus. 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 30 May 2013.