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Phase IB Dose Escalation Study of Bortezomib (VELCADE) Administered Weekly for 4 Weeks and Sunitinib (SU-011248) Administered Daily for 4 Weeks Followed by a 14 Day Rest in Patients With Refractory Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

Phase IB Dose Escalation Study of Bortezomib (VELCADE) Administered Weekly for 4 Weeks and Sunitinib (SU-011248) Administered Daily for 4 Weeks Followed by a 14 Day Rest in Patients With Refractory Solid Tumors


This is a Phase I study assessing the combination of bortezomib and sunitinib in patients
with solid tumors that are refractory to standard chemotherapy.

The study will take place in two stages. In both stages, patients will receive sunitinib
orally with food once daily for 4 weeks and bortezomib by injection into a vein once a week
for 4 weeks. This will be followed by 2 weeks of rest. This 6-week period is called one
cycle.

In stage 1, a maximum of 10 patients will be treated sequentially with increasing doses of
sunitinib (and a fixed dose of bortezomib). Each dose level must be well tolerated for the
next patient to start treatment at the next dose level. Whichever is the highest dose of
sunitinib that is well tolerated will then be used for the next stage.

In stage 2, a maximum of 20 patients will be treated sequentially with increasing doses of
bortezomib (and a fixed dose of sunitinib). Each dose level must be well tolerated for the
next patient to start treatment at the next dose level.

Together, the two stages will determine the highest doses of both sunitinib and bortezomib
that are well tolerated when given this combination. Determining these optimal doses is the
primary aim of this study. Patients will also be followed to see whether their tumor
responds to the treatment.

If a patient's cancer remains stable or improves, they can repeat the treatment cycles.
There is no defined end date to this study since patients will be followed for the duration
of their survival.


Inclusion Criteria:



Each patient must meet all of the following inclusion criteria to be enrolled in the
study:

- Refractory advanced solid tumor that has failed standard therapy.

- ECOG PS ≤ 2

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., 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 for contraception for the duration of
the study.

- Cardiac ejection fraction is more than 45%

Exclusion Criteria:

- Patient has a platelet count of <100 x 109/L within 14 days before enrollment.

- Patient has an absolute neutrophil count of ANC <1.0 x 109/L within 14 days before
enrollment.

- Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14
days before enrollment.

- AST, ALT, total bilirubin > twice the upper limits of normal.

- Received radiation to more than 30% of marrow volume

- Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days
before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conduction system abnormalities. Prior to study entry,
any ECG abnormality at Screening has to be documented by the investigator as not
medically relevant.

- Patient has hypersensitivity to sunitinib, bortezomib, boron or mannitol.

- Uncontrolled hypertension

- History of venous thromboembolic events.

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established 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.

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

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Hemorrhagic tendency of the tumor

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and toxicity of combination therapy with sunitinib and bortezomib

Outcome Time Frame:

every week

Safety Issue:

Yes

Principal Investigator

John Kauh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

3549

NCT ID:

NCT00720148

Start Date:

February 2008

Completion Date:

July 2010

Related Keywords:

  • Solid Tumors
  • Solid tumors
  • Neoplasms

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322