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A Phase I Study of Rapamycin (Sirolimus) With Bevacizumab in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Advanced Cancer, Metastatic Cancer

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Trial Information

A Phase I Study of Rapamycin (Sirolimus) With Bevacizumab in Patients With Advanced Malignancies

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

- current use of any herbal supplements or rifampin (rifampicin)

- prior history of hypertensive crisis or hypertensive encephalopathy

- history of myocardial infarction or unstable angina within 6 months of starting

- known CNS disease

- significant vascular disease

- symptomatic peripheral vascular disease

- evidence of bleeding diathesis or coagulopathy

- core biopsy or other minor surgical procedure (except placement of vascular
access device) within 7 days of starting study

- history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months of study start

- proteinuria at screening

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Ezra Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

May 2012

Related Keywords:

  • Advanced Cancer
  • Metastatic Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



University of ChicagoChicago, Illinois  60637