Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
- Conditions
- Neoplasms, Unknown Primary
- Interventions
- Registration Number
- NCT00193596
- Lead Sponsor
- SCRI Development Innovations, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regimen B Gemcitabine Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval Regimen A Etoposide Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval Regimen A Paclitaxel Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval Regimen A Carboplatin Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval Regimen B Irinotecan Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval
- Primary Outcome Measures
Name Time Method Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death 24 months Length of time, in months, that patients were alive from their first date of protocol treatment until death.
- Secondary Outcome Measures
Name Time Method 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 12 months Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Trial Locations
- Locations (31)
Tower Oncology
🇺🇸Beverly Hills, California, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Jackson Oncology Associates
🇺🇸Jackson, Mississippi, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Associates of SW Indiana
🇺🇸Evansville, Indiana, United States
Reading Hospital Regional Cancer Center
🇺🇸West Reading, Pennsylvania, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
South Texas Oncology and Hematology
🇺🇸San Antonio, Texas, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Phoebe Cancer Center
🇺🇸Albany, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
Wellstar Cancer Research
🇺🇸Marietta, Georgia, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Terrebonne General Medical Center
🇺🇸Houma, Louisiana, United States
Cancer Outreach Associates
🇺🇸Abingdon, Virginia, United States
Mercy Hospital Miami
🇺🇸Miami, Florida, United States
Watson Clinic Center for Cancer Care and Research
🇺🇸Lakeland, Florida, United States
Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
🇺🇸Mobile, Alabama, United States
Mercy Hospital
🇺🇸Portland, Maine, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
St. Joseph Mercy Oakland Hospital, Cancer Center
🇺🇸Pontiac, Michigan, United States
Consultants in Medical Oncology and Hematology
🇺🇸Drexel Hill, Pennsylvania, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Kingsport Hematology-Oncology
🇺🇸Kingsport, Tennessee, United States
Montana Cancer Institute Foundation
🇺🇸Missoula, Montana, United States