Non-small Cell Lung Cancer Study US75 (Z-PACT) (ZPACT)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086268
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Hide Study LocationsLocations
| United States, Alabama | |
| Clinical Research Consultants | |
| Hoover, Alabama, United States, 35216 | |
| United States, Arizona | |
| Arizona Oncology Assoc. | |
| Tucson, Arizona, United States, 85715 | |
| United States, Arkansas | |
| NEA Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| Highlands Oncology Group | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| NorthBay Cancer Center | |
| Fairfield, California, United States, 94533 | |
| UCLA | |
| Los Angeles, California, United States, 91401 | |
| Clinical Trials and Research Associates, Inc. | |
| Montebello, California, United States, 90640 | |
| Med. Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| Cancer Center of Santa Barbara | |
| Santa Barbara, California, United States, 93105 | |
| United States, Colorado | |
| Cancer Center of Colorado Springs | |
| Colorado Springs, Colorado, United States, 80907 | |
| Northern Hematology-Oncology | |
| Thornton, Colorado, United States, 80260 | |
| United States, Florida | |
| Lynn Regional Cancer Center | |
| Boca Raton, Florida, United States, 33428 | |
| New Hope Cancer Centers | |
| Hudson, Florida, United States, 34667 | |
| Oceola Cancer Center | |
| Kissimmee, Florida, United States, 34741 | |
| VA Medical Center | |
| Miami, Florida, United States, 33125 | |
| Innovative Medical Research of South Florida, Inc. | |
| Miami Shores, Florida, United States, 33138 | |
| NCH Healthcare System Oncology Research | |
| Naples, Florida, United States, 34102 | |
| Metcare Oncology | |
| Ormond Beach, Florida, United States, 32174 | |
| Hematology-Oncology Associates | |
| Pensacola, Florida, United States, 32501 | |
| AMIT SHAH Medical Group | |
| Sebring, Florida, United States, 33872 | |
| United States, Georgia | |
| Peachtree Hematology & Oncology | |
| Atlanta, Georgia, United States, 30309 | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Straub Clinic & Hospital | |
| Honolulu, Hawaii, United States, 96813 | |
| Kaiser Foundation Hospital | |
| Honolulu, Hawaii, United States, 96819 | |
| United States, Illinois | |
| Advocate Illinois Masonic Medical Center Creticos Cancer Center | |
| Chicago, Illinois, United States, 60657 | |
| OSF Center for Cancer Care | |
| Rockford, Illinois, United States, 61108 | |
| Springfield Clinic, LLP | |
| Springfield, Illinois, United States, 62703 | |
| United States, Indiana | |
| Central Indiana Cancer Centers | |
| Indianapolis, Indiana, United States, 46219 | |
| Oncology Institute of Greater Lafayette | |
| Lafayette, Indiana, United States, 47904 | |
| Community Hospital, Cancer Research Dept. | |
| Munster, Indiana, United States, 46321 | |
| Northern Indiana Oncology Associates | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| Cedar Valley Medical Specialists | |
| Waterloo, Iowa, United States, 50702 | |
| United States, Kansas | |
| Kansas City Cancer Ctr. South | |
| Lenexa, Kansas, United States, 66214 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Hematology/Oncology Clinic | |
| Baton Rouge, Louisiana, United States, 70808 | |
| LSU Health Sciences Center | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maine | |
| Maine Center for Cancer Medicine | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| Oncology Care Associates | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Massachusetts | |
| Berkshire Hematology Oncology PC | |
| Pittsfield, Massachusetts, United States, 01201 | |
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Kalamazoo Hematology & Oncology | |
| Kalamazoo, Michigan, United States, 49048 | |
| Mitchell Folbe, MD, PC | |
| Troy, Michigan, United States, 48085 | |
| United States, Minnesota | |
| Park Nicollett Institute | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| St. Louis Cancer Care | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Nebraska | |
| Southeast Nebraska Cancer Center | |
| Lincoln, Nebraska, United States, 68510 | |
| Odyssey Research | |
| Scottsbluff, Nebraska, United States, 69361 | |
| United States, Nevada | |
| Nevada Cancer Center | |
| Las Vegas, Nevada, United States, 89109 | |
| Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| East Orange VA Medical System | |
| East Orange, New Jersey, United States, 07018 | |
| Howell Office Plaza | |
| Howell, New Jersey, United States, 07731 | |
| Atlantic Hem Onc Associates, LLC | |
| Manasquan, New Jersey, United States, 08736 | |
| Hematology/Oncology Assoc. of South Jersey | |
| Mt. Holly, New Jersey, United States, 08060 | |
| Cancer Institute of New Jersey at Cooper University Hospital | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| New Mexico Oncology Hematology Consultants, Ltd. | |
| Albuquerque, New Mexico, United States, 87109 | |
| San Juan Regional Cancer Ctr. | |
| Farmington, New Mexico, United States, 87401 | |
| New Mexico Cancer Care Associates | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| Engracio Cortes, MD | |
| Bayside, New York, United States, 11361 | |
| Arena Oncology Assoc. | |
| Great Neck, New York, United States, 11021 | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 16642 | |
| Syracuse VA Medical Center | |
| Syracuse, New York, United States, 13210 | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28204 | |
| Southern Oncology Research | |
| Grifton, North Carolina, United States, 28530 | |
| United States, Ohio | |
| Barberton Citizens Hospital-Cancer Center | |
| Barberton, Ohio, United States, 44203 | |
| Dayton Clinical Oncology Program | |
| Dayton, Ohio, United States, 45429 | |
| Forum Health Cancer CareCenter | |
| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
| Cancer Specialists of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Hematology Oncology Associates | |
| Medford, Oregon, United States, 97504 | |
| United States, South Carolina | |
| Charleston Hematology Oncology | |
| Charleston, South Carolina, United States, 29403 | |
| Charleston Cancer Center | |
| Charleston, South Carolina, United States, 29406 | |
| Liberty Hematology-Oncology | |
| Columbia, South Carolina, United States, 29203 | |
| Santee Hematology/Oncology | |
| Sumter, South Carolina, United States, 29150 | |
| United States, Tennessee | |
| The Jones Clinic | |
| Germantown, Tennessee, United States, 38138 | |
| Knoxville Cancer Center | |
| Knoxville, Tennessee, United States, 27909 | |
| United States, Texas | |
| Cancer Specialists of South Texas | |
| Corpus Christi, Texas, United States, 78412 | |
| Tyler Hematology Oncology, PA | |
| Tyler, Texas, United States, 75701 | |
| Blood and Cancer Center of East Texas | |
| Tyler, Texas, United States, 75701 | |
| United States, Virginia | |
| Odyssey Research | |
| Belle Haven, Virginia, United States, 23306 | |
| Masoom Kandahari, MD | |
| Woodbridge, Virginia, United States, 22191 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
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 June 18, 2013