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

Metastatic Breast Cancer Clinical Trial

— K5-101  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988936
• Other study ID #: K5-101
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2009
• Last updated: August 21, 2012
• Start date: September 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Siemens Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Metastatic Breast Cancer
• Metastatic Colon/Rectum Cancer
• Non-squamous Non-small Cell Lung Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Beth Israel Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	UMDNJ	Newark	New Jersey
United States	Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

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