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Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma


- Participants will receive one of two treatment possibilities. Since no one knows which
of the study options is best, participants will be "randomized" to one fo the three
treatment groups.

- Group 1 will stop their current treatment with sunitinib and receive a dose of
bevacizumab once every 2 weeks. Group 2 will receive the standard treatment of
sunitinib with the addition of bevacizumab.

- All study participants will undergo the same study procedures. These study procedures
will include the following at intervals specified in the protocol: medical history
review; vital signs; physical exam; urine analysis; EKG and CT scan.


Inclusion Criteria:



- Histologically confirmed metastatic renal cell carcinoma with clear cell histology

- Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol

- Evidence of unidimensionally measurable disease based on RECIST criteria, with at
least 1 measurable lesion

- Radiographic evidence of disease progression defined by RECIST during or within 6
weeks of completion of sunitinib treatment

- Participants must have received at least 14 doses of sunitinib therapy

- Participants must enroll within 3 months of the last dose of sunitinib

- Males or females, age of 18 years or older

- ECOG Performance status 0-2

- Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical
procedures to NCI CTCAE version 3.0 grade 1 or less

- Laboratory values as defined in protocol

- 4 weeks or more must have elapsed from the time of major surgery and subjects must
have recovered from the procedure prior to day 1 of randomization

- No anticipated need for major surgical procedure during the course of the study

- 2 weeks or more must have elapsed from the time of minor surgery and subjects must
have recovered from the procedure prior to day 1 of randomization

- 4 weeks of more must have elapsed from the time of major radiotherapy prior to day 1
of randomization

Exclusion Criteria:

- Prior treatment with bevacizumab

- Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower

- Prior systemic therapy for RCC with > 2 regimens

- Systemic therapy other than sunitinib within 4 weeks of starting the study treatment

- Uncontrolled high blood pressure

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess
within 3 months prior to day 0

- Any of the following within the 6 months prior to sudy drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, cerebrovascular accident or transient ischemic attack, symptomatic congestive
heart failure, or ejection fraction < 30%

- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range without medication

- History of or known brain metastases or spinal cord compression

- NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Grade 3 or higher cardiac dysrhythmia or QT prolongation

- Concurrent use of proarrhythmic medications including terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
indapamide and flecainide

- Pregnancy or breastfeeding or inadequate contraception

- Significant thromboembolic event within 6 months

- Evidence of bleeding diathesis or coagulopathy

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

- Proteinuria at screening

- Known hypersensitivity to any component of bevacizumab

- Psychiatric illness/social situation that would limit compliance with study
requirements

- Previous or concurrent malignancy requiring active systemic therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab.

Outcome Time Frame:

Until tumor progression

Safety Issue:

No

Principal Investigator

M. Dror Michaelson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hosptial

Authority:

United States: Institutional Review Board

Study ID:

07-202

NCT ID:

NCT00556205

Start Date:

September 2009

Completion Date:

September 2009

Related Keywords:

  • Renal Cell Carcinoma
  • mRCC
  • sunitinib
  • bevacizumab
  • Carcinoma
  • Carcinoma, Renal Cell

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