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NCT01204203 · OUTCOME

Tumor Response Rate Following Zoledronic Acid (Zometa)

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) · Source last updated 2017-05-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of responders
Interval / dispersion
Not reported
Time frame
Baseline up to 28 months or until progressive disease or death

What was measured

The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.

Analysis population: Participants with advanced malignant pleural mesothelioma.

Groups in this outcome

Zometa

Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity. Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Zometa8

Reported measurements

Source class 1
Values in percentage of responders · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zometa12.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12.5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
groups
  1. description
    Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity. Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.
    id
    OG000
    title
    Zometa
param Type
NUMBER
population Description
Participants with advanced malignant pleural mesothelioma.
reporting Status
POSTED
time Frame
Baseline up to 28 months or until progressive disease or death
title
Tumor Response Rate Following Zoledronic Acid (Zometa)
type
PRIMARY
unit Of Measure
percentage of responders

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice