Status:
COMPLETED
Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma
Lead Sponsor:
London Health Sciences Centre
Conditions:
Breast Cancer
Endometrial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 dos...
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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy, including any of the following types:
- Renal cell
- Endometrial
- Breast
- Small cell lung carcinoma
- Lymphoma
- Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
- Measurable disease according to RECIST criteria
- No unstable primary CNS tumors or metastases
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- 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
- 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
- Exclusion criteria:
- 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:
- 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:
- Inclusion criteria:
- 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)
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00659568
Start Date
March 1 2008
End Date
August 1 2010
Last Update
May 30 2013
Active Locations (1)
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1
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6