Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hebei Tumor Hospital
ClinicalTrials.gov Identifier:
NCT01737216
First received: November 27, 2012
Last updated: December 28, 2012
Last verified: November 2012
  Purpose

Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.


Condition Intervention Phase
Lung Cancer
Drug: Zoledronic acid plus EP/TP
Drug: EP/TP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hebei Tumor Hospital:

Primary Outcome Measures:
  • Progression-free survival(PFS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival(OS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Bone mineral density(BMD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of life(QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid plus First-line chemotherapy Drug: Zoledronic acid plus EP/TP
Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
Active Comparator: First-line chemotherapy Drug: EP/TP
Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
Other Name: First-line chemotherapy

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Age ≥70 years
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  • Histologically or cytologically confirmed lung cancer
  • Did not receive bisphosphonate treatment

Exclusion Criteria:

  • Appear relapse and metastasis
  • receive other bisphosphonate treatment
  • Active or uncontrolled infection
  • Pregnant or lactating women
  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: NCT01737216

Locations
China, Hebei
Hebei Tumor Hospital
Shijiazhuang, Hebei, China, 050011
Sponsors and Collaborators
Hebei Tumor Hospital
Investigators
Principal Investigator: Wei Liu Hebei Tumor Hospital
  More Information

No publications provided

Responsible Party: Hebei Tumor Hospital
ClinicalTrials.gov Identifier: NCT01737216     History of Changes
Other Study ID Numbers: HBTH201, Hebei Tumor Hospital
Study First Received: November 27, 2012
Last Updated: December 28, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Hebei Tumor Hospital:
Aged
patients

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014