Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug (K5-101)

August 21, 2012 updated by: Siemens Molecular Imaging

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

A Pilot Phase II Study

The primary objective for this study is:

  • 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

The secondary objectives for this study are:

  • To continue safety evaluation by collection of safety data from all patients
  • To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies

Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study

Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of [F-18]RGD-K5 PET/CT (~ 3-4 hrs) and the standard [F-18]FDG PET/CT (~ 3-4 hrs) or diagnostic CT, followed by two [F-18]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and one after the fourth but before the fifth Avastin® treatment, and a follow up standard [F-18]FDG PET (~ 3-4 hrs) or diagnostic CT.

Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, three sets of [F-18]RGD-K5 dosing and imaging scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment

Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at approximately four to eight sites internationally

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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®.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697-5020
        • University of California, Irvine
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: [F-18]RDG-K5
Drug: [F-18]RGD-K5
Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with [F-18]RGD-K5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: (5) visits over a period of approximately 5 cycles of Avastin
(5) visits over a period of approximately 5 cycles of Avastin

Secondary Outcome Measures

Outcome Measure
Time Frame
To continue safety evaluation by collection of safety data from all patients.
Time Frame: (5) visits over a period of approximately 5 cycles of Avastin
(5) visits over a period of approximately 5 cycles of Avastin
To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies.
Time Frame: (5) visits over a period of approximately 5 cycles of Avastin
(5) visits over a period of approximately 5 cycles of Avastin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siemens Molecular Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (ESTIMATE)

October 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K5-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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