Non-small Cell Lung Cancer Study US75 (Z-PACT) (ZPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00086268
First received: June 29, 2004
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.


Condition Intervention Phase
Non Small Cell Lung Carcinoma
Drug: zoledronic acid
Drug: Taxotere
Drug: Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 250
Study Start Date: April 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zometa®
4mg monthly for 12 months from date of first chemotherapy dose
Drug: zoledronic acid Drug: Taxotere Drug: Carboplatin
No Intervention: no further treatment
Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female patients at least of 18 years old
  • Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery
  • Women must not be pregnant or attempting to become pregnant
  • Able and willing to sign informed consent

Exclusion Criteria:

  • Patients with cancer that has spread to the bone
  • Patients with cancer that has spread to the brain who are receiving treatment
  • Patients with kidney disease
  • Patients treated with other investigational drugs
  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: NCT00086268

  Show 80 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00086268     History of Changes
Obsolete Identifiers: NCT00093717
Other Study ID Numbers: CZOL446EUS75, US 75
Study First Received: June 29, 2004
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
lung cancer
ZPACT
US75
Bone Metastases

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Carboplatin
Zoledronic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014