Spots Global Cancer Trial Database for Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
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Trial Identification
Brief Title: Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
Official Title: A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site
Study ID: NCT00193596
Conditions
Study Description
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 treatment of patients with carcinoma of unknown primary site.
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 by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Kingsport Hematology-Oncology, Kingsport, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
South Texas Oncology and Hematology, San Antonio, Texas, United States
Cancer Outreach Associates, Abingdon, Virginia, United States
Contact Details
Name: John D. Hainsworth, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
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