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BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Brown University
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
Angela Taber MD, Brown University
ClinicalTrials.gov Identifier:
NCT02283749
First received: October 30, 2014
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
In this study patient's will receive the medicine Xofigo which is a radioactive drug that is FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously been tested to treat lung cancer that has spread to the bones. Your doctors are studying the effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones.

Condition Intervention Phase
Non Small Cell Lung Cancer With Bone Metastatses
Biological: Xofigo
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG L301: Xofigo Following Frontline-Line Chemotherapy For Patients With Non-Small Cell Lung Cancer and Bone Metastases

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Number of symptomatic skeletal events (SSE) in patients receiving Xofigo with NSCLC and bone metastases [ Time Frame: Approximately every 2 months for up to a year ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xofigo
Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.
Biological: Xofigo
This is a radio-isotope
Other Name: Radium -223

  Eligibility

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

Inclusion Criteria:

Age ≥ 18 years. Advanced non-small cell lung cancer with bone metastases. Stable or responding disease after completion of initial systemic chemotherapy as defined by RECIST criteria. Site to submit confirmation to BrUOG.

At least 3 weeks must have elapsed since completion of last chemotherapy or radiation prior to first dose of Xofigo. Patients are not permitted to receive any form of 'maintenance' chemotherapy or biologic/targeted anticancer therapy while being treated on this study Life expectancy of at least 12 weeks (3 months). Patients with treated brain metastases are allowed, but must have brain imaging showing evidence of stability since most recent treatment for brain mets, prior to first dose of Xofigo. Scan must be sent to BrUOG with registration information before patient is registered on study.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1. Required entry laboratory parameters within 14 days of study entry: White Blood Cell Count (WBC) ≥ 3,000/mm3; Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet (PLT) count ≥ 100,000/mm3; Hemoglobin (Hgb) > 9g/dl, Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ; Creatinine ≤ 1.5 x ULN; Albumin > 2.5 g/dL.

Concurrent treatment with bisphosphonates and denosumab is allowed. Information on start and stop date and drug with dose to be sent to BrUOG if patient to be treated concurrently.

Prior skeletal related events (pathologic fracture, radiation or surgery to bone, or spinal cord compression) are allowed if they have been managed and now patient is stable for 4 weeks prior to study entry. Must submit how events managed to BrUOG for documentation to confirm eligibility criterion. (For example, if a patient experienced a SSE and had radiation for 2 weeks they must then be stable for 4 weeks after the completion of radiation prior to study entry) Subjects must be able to understand and be willing to sign the written informed consent form.

All acute toxic effects related to prior treatment(s) must have resolved to NCI-CTCAE v4 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for alopecia.

Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.

Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician.

Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria:

Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible Untreated brain metastases. Any other serious illness or medical condition that in the investigator's opinion would interfere with protocol treatment, such as but not limited to: Any active infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 Grade 2: Cardiac failure New York Heart Association (NYHA) III or IV Women who are pregnant or breast-feeding. Inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments.

Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride.

Major surgery within 28 days of starting study drug. Central venous catheter placement is not considered major surgery.

  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: NCT02283749

Locations
United States, Rhode Island
Rhode Island Hospital and The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kristen M Mitchell    401-863-3000    kristen_mitchell@brown.edu   
Contact: Kayla Rosati, EdM    4018633000    kayla_rosati@brown.edu   
Principal Investigator: Angela Taber, MD         
Sub-Investigator: Richard Noto, MD         
Sub-Investigator: Don Yoo, MD         
Sub-Investigator: Thomas DiPetrillo, MD         
Sponsors and Collaborators
Angela Taber MD
Rhode Island Hospital
The Miriam Hospital
  More Information

Responsible Party: Angela Taber MD, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT02283749     History of Changes
Other Study ID Numbers: BrUOG 301 
Study First Received: October 30, 2014
Last Updated: December 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
NCSLC
lung cancer
non small cell lung cancer
bone metastases

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on April 27, 2016