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| Sponsored by: |
Agouron Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004199 |
Purpose
RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor.
Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: prinomastat |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer |
| Study Start Date: | March 1999 |
OBJECTIVES: I. Compare the overall survival, progression free survival, symptomatic progression free survival, and one year survival of patients with metastatic or recurrent non-small cell lung cancer treated with prinomastat (AG3340) or placebo in combination with gemcitabine and cisplatin. II. Compare the disease response and duration of response in these patients on these regimens. III. Compare the quality of life of these patients on these regimens. IV. Evaluate the safety of these regimens in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine IV on days 1 and 8 and cisplatin IV on day 1. Courses repeat every 3 weeks.
PROJECTED ACCRUAL: Approximately 420 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Stage IV or recurrent or T4 lesion non-small cell lung cancer Measurable or evaluable disease No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, California | |
| Agouron Pharmaceuticals, Inc. | |
| La Jolla, California, United States, 92037 | |
| Study Chair: | Mary Collier | Agouron Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000067442, AG-3340-017 |
| Study First Received: | January 21, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004199 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Immunologic Factors Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Respiratory Tract Diseases |
Cisplatin Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
