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

Phase 3

Completed

• Conditions: Non Small Cell Lung Carcinoma
• Interventions: Drug: zoledronic acid; Drug: Taxotere; Drug: Carboplatin

• Registration Number: NCT00086268
• Lead Sponsor: Novartis Pharmaceuticals

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 available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-06-29
• Study First Submitted QC: 2004-06-30
• Study First Posted: 2004-07-01
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zometa®	Taxotere	4mg monthly for 12 months from date of first chemotherapy dose
Zometa®	Carboplatin	4mg monthly for 12 months from date of first chemotherapy dose
Zometa®	zoledronic acid	4mg monthly for 12 months from date of first chemotherapy dose

Trial Locations

Locations (79)

Clinical Research Consultants; 🇺🇸 Hoover, Alabama, United States

Arizona Oncology Assoc.; 🇺🇸 Tucson, Arizona, United States

NEA Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

NorthBay Cancer Center; 🇺🇸 Fairfield, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Clinical Trials and Research Associates, Inc.; 🇺🇸 Montebello, California, United States

Med. Oncology Care Associates; 🇺🇸 Orange, California, United States

Cancer Center of Santa Barbara; 🇺🇸 Santa Barbara, California, United States

Cancer Center of Colorado Springs; 🇺🇸 Colorado Springs, Colorado, United States

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