Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug (K5-101)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Irvine, California, United States, 92697-5020
- University of California, Irvine
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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New Jersey
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Newark, New Jersey, United States, 07103
- UMDNJ
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New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19124
- Eastern Regional Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K5-101
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