Status:
COMPLETED
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
AstraZeneca
Pharmacia and Upjohn
Conditions:
Neoplasms, Unknown Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line ...
Detailed Description
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: * Paclitaxel + Carboplatin + Etoposide * Irinotecan + Gemcitabine Patients will be stratified ...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Carcinoma of unknown primary site
- Biopsy-proven metastatic carcinoma
- Able to perform activities of daily living with minimal assistance
- No previous treatment with any systemic therapy
- Measurable or evaluable disease
- Adequate bone marrow, liver and kidney function
- Understand the nature of this study and give written informed consent
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Age \< 18 years
- Uncontrolled brain metastases and meningeal involvement
- Other uncontrolled malignancies
- Women pregnant or lactating
- Recent history of significant cardiovascular disease
- Severe or uncontrolled systemic disease
- Other significant clinical disorder
- Clinically active interstitial lung disease
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00193596
Start Date
September 1 2003
End Date
June 1 2009
Last Update
May 3 2013
Active Locations (31)
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1
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
2
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
3
Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
Mobile, Alabama, United States, 36608
4
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401