Rapamycin Plus Bevacizumab in Advanced Cancers

Completed · Phase 1

Conditions studied: Advanced Cancer, Metastatic Cancer

In brief

The goal of this trial is to determine the toxicity and maximum dose of rapamycin and bevacizumab given together to subjects with advanced cancers. This study will also look at the pharmacokinetics and antitumor activity of the combination.

Key facts

Study ID: NCT00667485
Run by: University of Chicago
People needed: 28
Starts: 2008-04-01
Expected to finish: 2012-05-01
Last updated by the study team: 2014-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Metastatic or unresectable solid tumor for which standard treatments do not exist or are no longer effective
Performance status of 0-1
Measurable or non-measurable disease
Life expectancy of at least 12 weeks
No anticipated need of other cancer treatments within the next 4 weeks
18 years or older
Negative pregnancy test for women able to have children, agreement to use a medically accepted birth control method while receiving the study drugs and for at least 2 weeks after stopping, not breast feeding
Ability to understand and willingness to sign a written informed consent document
No evidence of bleeding diathesis
Patients without lung cancer receiving anti-coagulation treatment can participate
Adequate organ and marrow function:
ALT and AST less than or equal to 2.5 times the institutional ULN (less than 5 times for patients with liver involvement)
hemoglobin at least 9g/dL
absolute neutrophil count at least 1,500/µL
platelets at least 100,000/µL
total bilirubin less than or equal to 1.5 times the institutional ULN
creatinine less than or equal to 1.5 times the institutional ULN

You may not qualify if…

Prior treatment with both bevacizumab and an mTOR inhibitor is not allowed. Prior treatment with both bevacizumab OR mTOR inhibitor (including rapamycin) is allowed. Patients who had a grade 3 or greater side effect with either bevacizumab or an mTOR inhibitor cannot take part in this study.
Chemotherapy or Immunotherapy within the 4 weeks of study start
Radiotherapy within 14 days of study start
Cannot be receiving any other investigational drugs or any other cancer treatments while on study (with the exception of androgen ablating agents for patients with prostate cancer).
Patients with squamous non-small cell lung cancer (NSCLC)
Patients with lung cancer or lung metastases:
on full dose anticoagulation
taking 325mg aspirin per day
on non-steroidal anti-inflammatory agents
HIV positive patients receiving combination anti-retroviral therapy are excluded due to potential for serious infections while taking marrow suppressing agents
Ongoing illness or medical exclusions, including but not limited to:
active or ongoing infection
symptomatic congestive heart failure
uncontrolled hypertension despite optimal medical management
cardiac arrhythmia except paroxysmal atrial fibrillation
psychiatric illness/social situations that would limit compliance with study requirements
history of organ allograft, bone marrow or peripheral blood stem cell transplant
known or suspect allergy to bevacizumab or rapamycin
seizure disorder treated with steroid or anticonvulsant therapy
thrombotic or embolic events within 6 months of starting study
pulmonary hemorrhage/bleeding within 12 weeks of starting study (grade 3 event within 4 weeks of first dose of drug). Patients with a history of pulmonary hemorrhage/bleeding cannot be on full dose anticoagulation.
pulmonary fibrosis or interstitial lung disease
serious non-healing wound, ulcer or bone fracture
Major surgery, open biopsy or a traumatic injury within 4 weeks of starting study drug
anticipated need for major surgery while on-study

Where it is running

University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.