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
18 Years
N/A
Both
Neoplasms, Unknown Primary
Trial Information
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
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.
Inclusion Criteria:
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 Criteria:
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Outcome Description:
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
John D. Hainsworth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Institutional Review Board
Study ID:
SCRI UNKPRI 12
NCT ID:
NCT00193596
Start Date:
September 2003
Completion Date:
June 2009
Related Keywords:
- Neoplasms, Unknown Primary
- Neoplasms, Unknown Primary
- Neoplasms
- Carcinoma
- Neoplasms, Unknown Primary
Name | Location |
|---|---|
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| Northeast Arkansas Clinic | Jonesboro, Arkansas 72401-3125 |
| South Texas Oncology and Hematology | San Antonio, Texas 78229 |
| Terrebonne General Medical Center | Houma, Louisiana 70360 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
| Methodist Cancer Center | Omaha, Nebraska 68114 |
| Clearview Cancer Institute | Huntsville, Alabama 35805 |
| Mercy Hospital | Portland, Maine 04101 |
| Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Kingsport Hematology-Oncology | Kingsport, Tennessee 37660 |
| Jackson Oncology Associates | Jackson, Mississippi 39202 |
| Tower Oncology | Beverly Hills, California 90211 |
| Wellstar Cancer Research | Marietta, Georgia 30060 |
| Oncology Hematology Care | Cincinnati, Ohio 45242 |
| Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |
| Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
| Graves-Gilbert Clinic | Bowling Green, Kentucky 42101 |
| Consultants in Medical Oncology and Hematology | Drexel Hill, Pennsylvania 19026 |
| Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group | Mobile, Alabama 36608 |
| Mercy Hospital Miami | Miami, Florida 33133 |
| Phoebe Cancer Center | Albany, Georgia 31701 |
| St. Joseph Mercy Oakland Hospital, Cancer Center | Pontiac, Michigan 48341 |
| Montana Cancer Institute Foundation | Missoula, Montana 59802 |
| Aultman Hospital | Canton, Ohio 44710 |
| Reading Hospital Regional Cancer Center | West Reading, Pennsylvania 19612 |
| Cancer Outreach Associates | Abingdon, Virginia 24211 |
