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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
1000 mg/m2 IV, days 1 and 8, in regimen B
1000 mg/m2 IV days 1 and 8 in regimen B
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Time frame: 24 months
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Time frame: 12 months
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200 mg/m2 by 1-hour IV infusion, day 1, regimen A
Area under the curve (AUC) 6.0 IV, day 1, regimen A
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
...and 21 more locations