Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
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
1 other identifier
interventional
198
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2003
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
May 3, 2013
CompletedMay 3, 2013
March 1, 2013
5 years
September 12, 2005
January 14, 2013
March 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (1)
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
Study Arms (2)
Regimen A
EXPERIMENTALPaclitaxel 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
EXPERIMENTALIrinotecan 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
Interventions
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
Area under the curve (AUC) 6.0 IV, day 1, regimen A
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- AstraZenecacollaborator
- Pharmacia and Upjohncollaborator
- Eli Lilly and Companycollaborator
Study Sites (31)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207, United States
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
Mobile, Alabama, 36608, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Tower Oncology
Beverly Hills, California, 90211, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Mercy Hospital Miami
Miami, Florida, 33133, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Phoebe Cancer Center
Albany, Georgia, 31701, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Wellstar Cancer Research
Marietta, Georgia, 30060, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Mercy Hospital
Portland, Maine, 04101, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
St. Joseph Mercy Oakland Hospital, Cancer Center
Pontiac, Michigan, 48341, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
Montana Cancer Institute Foundation
Missoula, Montana, 59802, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, 19026, United States
Reading Hospital Regional Cancer Center
West Reading, Pennsylvania, 19612, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Kingsport Hematology-Oncology
Kingsport, Tennessee, 37660, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
South Texas Oncology and Hematology
San Antonio, Texas, 78258, United States
Cancer Outreach Associates
Abingdon, Virginia, 24211, United States
Related Publications (1)
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.
PMID: 20164695RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
September 1, 2003
Primary Completion
September 1, 2008
Study Completion
June 1, 2009
Last Updated
May 3, 2013
Results First Posted
May 3, 2013
Record last verified: 2013-03