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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT00988936
First received: October 1, 2009
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Metastatic Colon/Rectum Cancer
Non-squamous Non-small Cell Lung Cancer
Drug: [F-18]RGD-K5
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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®.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988936

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697-5020
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07103
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Siemens Molecular Imaging
Investigators
Study Director: Edward Aten, MD President, Certus International
  More Information

No publications provided

Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT00988936     History of Changes
Other Study ID Numbers: K5-101
Study First Received: October 1, 2009
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:
[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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Breast Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014