Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
NCT ID: NCT00193596
Last Updated: 2013-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2003-09-30
2009-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen A
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
Etoposide
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
Paclitaxel
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
Carboplatin
Area under the curve (AUC) 6.0 IV, day 1, regimen A
Regimen B
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
Gemcitabine
1000 mg/m2 IV, days 1 and 8, in regimen B
Irinotecan
1000 mg/m2 IV days 1 and 8 in regimen B
Interventions
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Etoposide
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
Gemcitabine
1000 mg/m2 IV, days 1 and 8, in regimen B
Irinotecan
1000 mg/m2 IV days 1 and 8 in regimen B
Paclitaxel
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
Carboplatin
Area under the curve (AUC) 6.0 IV, day 1, regimen A
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Pharmacia and Upjohn
INDUSTRY
Eli Lilly and Company
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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John D. Hainsworth, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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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
Countries
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References
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Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, Farley C, West-Osterfield K, Lane CM, Cescon T, Bury MJ, Greco FA. Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown primary site: a randomized, phase III Sarah Cannon Oncology Research Consortium Trial. Cancer J. 2010 Jan-Feb;16(1):70-5. doi: 10.1097/PPO.0b013e3181c6aa89.
Related Links
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Published article in The Cancer Journal
Other Identifiers
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SCRI UNKPRI 12
Identifier Type: -
Identifier Source: org_study_id
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