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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118131 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: cisplatin Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer |
Estimated Enrollment: | 76 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New Jersey | |
Cancer Institute of New Jersey at Hamilton | |
Hamilton, New Jersey, United States, 08690 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
Central Jersey Oncology Center, PA - East Brunswick | |
East Brunswick, New Jersey, United States, 08816 | |
CentraState Medical Center | |
Freehold, New Jersey, United States, 07728 | |
Somerset Medical Center | |
Somerville, New Jersey, United States, 08876 | |
Overlook Hospital | |
Summit, New Jersey, United States, 07901 | |
Raritan Bay Medical Center | |
Perth Amboy, New Jersey, United States, 08861 | |
Saint Peter's University Hospital | |
New Brunswick, New Jersey, United States, 08903 | |
Mountainside Hospital Cancer Center | |
Montclair, New Jersey, United States, 07042 |
Principal Investigator: | Joseph Aisner, MD | Cancer Institute of New Jersey |
Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Joseph Aisner ) |
Study ID Numbers: | CDR0000433488, CINJ-030302, CINJ-4672, CINJ-NJ1503, CINJ-5065 |
Study First Received: | July 8, 2005 |
Last Updated: | June 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00118131 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Docetaxel Thoracic Neoplasms Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |