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A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer, Non-squamous Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug


The aim of this pilot study is to examine the utility of a new molecular imaging tracer,
[F-18]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with
Avastin® (Bevacizumab) plus standard chemotherapy. The changes of [F-18]RGD-K5 PET/CT image
scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab)
will be evaluated. The hypothesis for this study is that changes in the uptake of
[F-18]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or
angiogenesis. This pilot study will help to define if changes in uptake of [F-18]RGD-K5 are
an early indicator of treatment efficacy to Avastin®.


Inclusion Criteria:



- Patient is >18 years and male or female of any race / ethnicity

- Patient or patient's legally acceptable representative provides written informed
consent and willing to comply with protocol requirements

- Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for
their cancer care; treatment management will be made by the treating medical
oncologists (According to the package insert for Avastin®, it is administered as an
IV infusion every 3 weeks for nonsquamous non-small cell lung cancer, and every 2
weeks for metastatic breast cancer, colon or rectum cancer)

- Patient will be scheduled to have a clinical [F-18]FDG-PET/CT or diagnostic CT
pre-treatment after the fourth but before the fifth Avastin® treatment

Exclusion Criteria:

- Patient is not capable of complying with study procedures

- Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of
the following:

- Confirming in medical history that the patient is postmenopausal for a minimum
of one year, or surgically sterile

- Confirming the patient is using one of the following methods of birth control
for a minimum of one month prior to entry into this study: IUD, oral
contraceptives, Depo-Provera, or Norplant

- Confirming a negative urine dipstick test taken the morning of receiving the
[F-18]RGD-K5

- Patient has a severe hepatic or renal disease as defined by previous medical history
or abnormal renal and hepatic functions determined by lab results not within the
following ranges, or in the opinion of the Investigator, the values are not
acceptable for the patient to be included:

- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal

- Serum creatinine ≤ 2x institutional upper limits of normal

- BUN within 2x institutional upper limits of normal

- Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S
deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not
within the following ranges, or in the opinion of the Investigator, the values
are not acceptable for the patient to be included: Platelet counts of < 75 x
103/μL

- Patient has known sensitivity to any components of Avastin® such as recombinant human
or humanized antibodies

- Patient has been involved in an investigative, radioactive research procedure within
7 days and during the study participation period

- Patient will participate in experimental therapy procedures while participating in
this clinical trial

- Patient has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete data or data quality to
achieve study objectives, or complete study and/or post-dose follow-up examinations

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed.

Outcome Time Frame:

(5) visits over a period of approximately 5 cycles of Avastin

Safety Issue:

No

Principal Investigator

Edward Aten, MD

Investigator Role:

Study Director

Investigator Affiliation:

President, Certus International

Authority:

United States: Food and Drug Administration

Study ID:

K5-101

NCT ID:

NCT00988936

Start Date:

September 2009

Completion Date:

May 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Colon/Rectum Cancer
  • Non-squamous Non-small Cell Lung Cancer
  • [F-18]RGD-K5
  • RGD-K5
  • K5-101
  • Avastin
  • angiogenesis
  • anti-angiogenesis
  • chemotherapy
  • breast cancer
  • colon cancer
  • rectal cancer
  • lung cancer
  • non-squamous
  • non small cell
  • Breast Neoplasms
  • Rectal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Mount Sinai School of Medicine New York, New York  10029
Beth Israel Medical Center New York, New York  10003
Cedars-Sinai Medical Center Los Angeles, California  90048
University of California, Irvine Orange, California  92868
UMDNJ Newark, New Jersey  07107
Eastern Regional Medical Center Philadelphia, Pennsylvania  
Hospital of University of Pennsylvania Philadelphia, Pennsylvania  19104