Trial Outcomes & Findings for Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer (NCT NCT01004510)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

3 months

Results posted on

2012-12-04

Participant milestones
Measure	Zoledronic Acid Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Zoledronic Acid Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
Overall Study Adverse Event	1

Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer

Baseline characteristics by cohort
Measure	Zoledronic Acid n=3 Participants Monthly zoledronic acid in addition to chemotherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
control of malignant pleural effusions in non small cell lung cancer	3 participants n=5 Participants

Timeframe: 3 months

Population: Too few patients enrolled to analyze data

Outcome data not reported

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Zoledronic Acid n=3 participants at risk Monthly zoledronic acid in addition to chemotherapy
Respiratory, thoracic and mediastinal disorders Admitted to hospital with diagnosis of pneumonia and anemia	33.3% 1/3 • Number of events 1 • Although the protocol was approved to begin enrollment 9/25/09, Adverse event data was collected from first patient enrollment 1/4/10-through study termination on 4/26/11. Aproximately 1 year, 4 months.

Other adverse events
Measure	Zoledronic Acid n=3 participants at risk Monthly zoledronic acid in addition to chemotherapy
Skin and subcutaneous tissue disorders erythematous prurtic rash over chest and abdomen	33.3% 1/3 • Number of events 1 • Although the protocol was approved to begin enrollment 9/25/09, Adverse event data was collected from first patient enrollment 1/4/10-through study termination on 4/26/11. Aproximately 1 year, 4 months.

Rochester General Hospital

Phone: 585-922-4409