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

NCT00988936 | Completed Phase 2

• 1 other identifier: K5-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Metastatic Breast Cancer; Metastatic Colon/Rectum Cancer; Non-squamous Non-small Cell Lung Cancer

Keywords

[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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To continue safety evaluation by collection of safety data from all patients.

  (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.

  (5) visits over a period of approximately 5 cycles of Avastin

Study Arms (1)

[F-18]RDG-K5

EXPERIMENTAL

Drug: [F-18]RGD-K5

Interventions

[F-18]RGD-K5 DRUG

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

[F-18]RDG-K5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (8)

University of California, Irvine

Irvine, California, 92697-5020, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UMDNJ

Newark, New Jersey, 07103, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Edward Aten, MD

  President, Certus International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

US (8)