Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

Completed · Phase 3

Conditions studied: Neoplasms, Unknown Primary

In brief

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 treatment of patients with carcinoma of unknown primary site.

Key facts

Study ID

NCT00193596

Run by

SCRI Development Innovations, LLC

People needed

198

Starts

2003-09-01

Expected to finish

2009-06-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Northeast Alabama Regional Medical Center — Anniston, Alabama, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States
• Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group — Mobile, Alabama, United States
• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Tower Oncology — Beverly Hills, California, United States
• Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
• Mercy Hospital Miami — Miami, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Phoebe Cancer Center — Albany, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Wellstar Cancer Research — Marietta, Georgia, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
• Consultants in Blood Disorders and Cancer — Louisville, Kentucky, United States
• Terrebonne General Medical Center — Houma, Louisiana, United States
• Mercy Hospital — Portland, Maine, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• St. Joseph Mercy Oakland Hospital, Cancer Center — Pontiac, Michigan, United States
• Jackson Oncology Associates — Jackson, Mississippi, United States
• Montana Cancer Institute Foundation — Missoula, Montana, United States
• Methodist Cancer Center — Omaha, Nebraska, United States
• Aultman Hospital — Canton, Ohio, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Consultants in Medical Oncology and Hematology — Drexel Hill, Pennsylvania, United States
• Reading Hospital Regional Cancer Center — West Reading, Pennsylvania, United States

Full record on ClinicalTrials.gov

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