Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma
A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
3 other identifiers
interventional
28
1 country
1
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 dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMay 30, 2013
August 1, 2010
1.9 years
April 15, 2008
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- Recovered from all prior therapy
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Mackenzie, MD
London Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 16, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2010
Study Completion
August 1, 2010
Last Updated
May 30, 2013
Record last verified: 2010-08