Prinomastat and Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Non-small Cell Lung Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00004199 |
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Recruitment Status :
Completed
First Posted : July 19, 2004
Last Update Posted : August 8, 2012
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| Tracking Information | ||||
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| First Submitted Date ICMJE | January 21, 2000 | |||
| First Posted Date ICMJE | July 19, 2004 | |||
| Last Update Posted Date | August 8, 2012 | |||
| Study Start Date ICMJE | March 1999 | |||
| Actual Primary Completion Date | July 2001 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE | Not Provided | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Prinomastat and Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Non-small Cell Lung Cancer | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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| Condition ICMJE | Lung Cancer | |||
| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | Not Provided | |||
| Original Enrollment ICMJE | Not Provided | |||
| Study Completion Date ICMJE | Not Provided | |||
| Actual Primary Completion Date | July 2001 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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 |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00004199 | |||
| Other Study ID Numbers ICMJE | AG-3340-017 CDR0000067442 |
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| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | August 2012 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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