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Phase 1/Phase 2
18 Years
Open (Enrolling)
Renal Cell Cancer

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Trial Information

Inclusion Criteria:

- Distant metastatic (TX NX M1) or locally recurrent renal cell carcinoma not amenable
to cure by surgical or other means

- Measurable or non-measurable (evaluable) disease either on imaging scan or physical

- Pathological confirmation of the diagnosis of renal cell carcinoma either during
prior nephrectomy or by biopsy of a primary or metastatic lesion - provision of a
paraffin-embedded tissue block to confirm the diagnosis and allow molecular
correlate assessment is required.

- ECOG performance status 0 or 1.

- Patients must have an AGC of greater than or equal to 1,500/mm3 and a platelet count
of greater than or equal to 100,000/mm3. These tests must be obtained within 28 days
of registration.

- Patients must have a calculated or measured creatinine clearance greater than or
equal to 40 ml/min obtained within 28 days prior to registration.

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Male subject agrees to use an acceptable method of contraception for the duration of
the study.

- May have been treated with interleukin and/or interferon but must not have had more
than one line of prior cytotoxic chemotherapy

- May have had up to one biologic therapy provided they have not had bortezomib or

- May have had up to 2 prior vaccine therapies

- May have been treated with radiation therapy, provided there are measurable or
evaluable lesions outside the field of radiation

- May have had radiation provided the patient has recovered from the side effects of
the therapy (typically 2 weeks after final fraction) and less than 30% of the total
bone marrow has been irradiated

Exclusion Criteria:

- Brain metastases or history of brain metastases

- History of deep vein thrombosis or thromboembolic disease within 1 year or requiring
ongoing anticoagulant therapy

- History of stroke or myocardial infarction within six months

- Other major illnesses likely to limit survival including poorly controlled
hypertension (BP > 150/100 mmHg) or symptomatic or clinically significant peripheral
vascular disease or angina pectoris

- Unstable angina

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Urine protein:creatinine ratio greater than or equal to 1.0 at screening

- Evidence of bleeding diathesis or coagulopathy.

- Major surgical procedure, open biopsy, significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study

- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to Day 0

- Pregnant (positive pregnancy test) or lactating; confirmation that female subject is
not pregnant by a negative serum beta-human chorionic gonadotropin (beta-hCG)
pregnancy test result obtained during screening. Pregnancy testing is not required
for post-menopausal or surgically sterilized women.

- Inability to comply with study and/or follow-up procedures

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Neuropathy at baseline > grade 1

- Patient has received other investigational drugs within 14 days before enrollment

- Patient has hypersensitivity to bevacizumab, bortezomib, boron or mannitol

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Toxicity as assessed by CTCAE 3.0 undertaken every 3 weeks

Safety Issue:


Principal Investigator

David Quinn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

December 2014

Related Keywords:

  • Renal Cell Cancer
  • Carcinoma, Renal Cell



Norris Comprehensive Cancer Center Los Angeles, California  90033