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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2004

Last Updated Date

April 15, 2013

Start Date ^ICMJE

April 2004

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Proportion of patients without disease progression

Change History

Complete list of historical versions of study NCT00086268 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Time to disease progression
Response rate
Time to progression in bone
Overall survival
Safety

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Non Small Cell Lung Carcinoma

Intervention ^ICMJE

Drug: zoledronic acid
Drug: Taxotere
Drug: Carboplatin

Study Arm (s)

Experimental: Zometa®
4mg monthly for 12 months from date of first chemotherapy dose
Interventions:
- 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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00086268

Other Study ID Numbers ^ICMJE

CZOL446EUS75, US 75

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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