Trial Outcomes & Findings for To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer (NCT NCT00697619)

Last Updated: 2012-03-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline, the first, second and third month

Results posted on

2012-03-07

Participant milestones
Measure	Test Group Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Control Group Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Overall Study STARTED	30	30
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal
Measure	Test Group Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Control Group Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Overall Study Lack of Efficacy	2	2
Overall Study Adverse Event	4	6

To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

Baseline characteristics by cohort
Measure	Test Group n=30 Participants Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Control Group n=30 Participants Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	46 years STANDARD_DEVIATION 10 • n=5 Participants	41 years STANDARD_DEVIATION 11 • n=7 Participants	44 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

Timeframe: Baseline, the first, second and third month

Outcome measures
Measure	Test Group n=30 Participants Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Control Group n=29 Participants Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . Baseline	75 nM /mM Standard Error 15	94 nM /mM Standard Error 16
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . the first month	29 nM /mM Standard Error 12	88 nM /mM Standard Error 23
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . the second month	17 nM /mM Standard Error 7	52 nM /mM Standard Error 21
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . the third month	11 nM /mM Standard Error 20	45 nM /mM Standard Error 27

Serious events: 15 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious events: 17 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events
Measure	Test Group n=30 participants at risk Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Control Group n=29 participants at risk Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Blood and lymphatic system disorders Leukopenia	43.3% 13/30	44.8% 13/29
Blood and lymphatic system disorders Neutropenia	26.7% 8/30	24.1% 7/29

Other adverse events
Measure	Test Group n=30 participants at risk Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.	Control Group n=29 participants at risk Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
General disorders bone pain, nausea, anemia, vomiting,constipation, dyspnea and fatigue	50.0% 15/30	55.2% 16/29

Sun Yat-sen University Cancer Centre

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