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

BrUOG L301: Xofigo Following Frontline-Line Chemotherapy For Patients With Non-Small Cell Lung Cancer and Bone Metastases

NCT02283749•Angela Taber MD

View on ClinicalTrials.gov

Summary

Detailed Description

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. Your doctors will also be evaluating changes in health related quality of life using the EORC QL-C20 and QOL-BM22 questionnaires. They will also evaluate the impact of treatment on the Alkaline phosphate levels (by way of lab draws) in patients and measure the progression free survival and overall survival of patients with stable or responding disease after the front line chemotherapy treated with Xofigo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 and 4 weeks since last 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. For patients with brain metastases only, brain imaging is required. Patients who do not have brain metastases or symptoms of potential brain metastases are not required to have baseline brain imaging, but this must be confirmed in writing
•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)
+5 more criteria

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.

Locations (1)

Rhode Island Hospital and The Miriam Hospital

Providence, Rhode Island, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

July 5, 2018

Completion Date

November 13, 2018

Last Updated

February 2, 2021

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer With Bone Metastatses

Interventions

Xofigo

BIOLOGICAL