The primary objective for this study is:• To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response toAvastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full courseof treatment is completedThe…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
The secondary objective for this study is:
• To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study
design
and conduct of future studies
Background summary
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
Protocol Number: K5-101
Date: 22 June 2009 FINAL VERSION
Design:
An open label, non-randomized, uncontrolled, single group assignment, pilot
efficacy study
The participation of the NKI/AVL will focus on the inclusion of 10 patients met
colorectal liver metastases.
Study objective
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 objective for this study is:
• To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study
design
and conduct of future studies
Study design
An open label, non-randomized, uncontrolled, single group assignment, pilot
efficacy study
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.
The NKI/AVL will focus on the inclusion of patients met colorectal liver
metastases.
Study burden and risks
Very limited:
1. RGD-K5 presents no known risks either from preclinical studies in cell lines
and animals or from clinical investigations of this compound in humans. A
safety profile of [F-18]RGD-K5 was obtained from our exploratory study in
humans. Also, there are no adverse events reported for structurally similar
compounds to RGD-K5 that have been investigated in human studies. Based on the
findings obtained from pre-clinical evaluation and clinical testing in humans,
and the very low chemical mass and excellent purity profile of [F-18]RGD-K5 to
be administered as a single dose, [F-18]RGD-K5 presents no anticipated risks
for this agent in humans.
The [F-18]RGD-K5 radiation dosimetry estimates derived from the human
biodistribution study indicates the radiation
dosimetry to be similar to many other radiodiagnostic agents, and does not
represent any undue risk.
2. In each patient included at the NKI/AVL the borders of one liver lesion will
be marked before start of the neo-adjuvant chemotherapy. The punction the
radiologist needs to perform to achieve this, implies a very limited risk of
bleeding and infection.
200 Chester Field Parkway
Malvern, PA 19355
US
200 Chester Field Parkway
Malvern, PA 19355
US
Listed location countries
Age
Inclusion criteria
• Patient is >18 years and male or female of any race / ethnicity
• Patient 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 treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for non-squamous 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 pretreatment, and 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
• 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:
o AST (SGOT)/ALT (SGPT) <= 2.5 x institutional upper limits of normal
o Serum creatinine <= 2x institutional upper limits of normal
o 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:
o 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 or 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-018874-19-NL |
| CCMO | NL30174.031.10 |