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Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

Primary Purpose

Neoplasms, Unknown Primary

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Etoposide
Gemcitabine
Irinotecan
Paclitaxel
Carboplatin
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Unknown Primary focused on measuring Neoplasms, Unknown Primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Clearview Cancer Institute
  • Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
  • Northeast Arkansas Clinic
  • Tower Oncology
  • Watson Clinic Center for Cancer Care and Research
  • Mercy Hospital Miami
  • Florida Hospital Cancer Institute
  • Phoebe Cancer Center
  • Northeast Georgia Medical Center
  • Wellstar Cancer Research
  • Oncology Hematology Associates of SW Indiana
  • Graves-Gilbert Clinic
  • Consultants in Blood Disorders and Cancer
  • Terrebonne General Medical Center
  • Mercy Hospital
  • Grand Rapids Clinical Oncology Program
  • St. Joseph Mercy Oakland Hospital, Cancer Center
  • Jackson Oncology Associates
  • Montana Cancer Institute Foundation
  • Methodist Cancer Center
  • Aultman Hospital
  • Oncology Hematology Care
  • Consultants in Medical Oncology and Hematology
  • Reading Hospital Regional Cancer Center
  • Spartanburg Regional Medical Center
  • Kingsport Hematology-Oncology
  • Thompson Cancer Survival Center
  • Tennessee Oncology, PLLC
  • South Texas Oncology and Hematology
  • Cancer Outreach Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regimen A

Regimen B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
March 22, 2013
Sponsor
SCRI Development Innovations, LLC
Collaborators
AstraZeneca, Pharmacia and Upjohn, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00193596
Brief Title
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
AstraZeneca, Pharmacia and Upjohn, Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Unknown Primary
Keywords
Neoplasms, Unknown Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Experimental
Arm Description
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
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Etopophos, Toposar
Intervention Description
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1000 mg/m2 IV, days 1 and 8, in regimen B
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar
Intervention Description
1000 mg/m2 IV days 1 and 8 in regimen B
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Area under the curve (AUC) 6.0 IV, day 1, regimen A
Primary Outcome Measure Information:
Title
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Description
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Northeast Arkansas Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Tower Oncology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Watson Clinic Center for Cancer Care and Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Mercy Hospital Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Phoebe Cancer Center
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Wellstar Cancer Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Oncology Hematology Associates of SW Indiana
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Graves-Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Terrebonne General Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Mercy Hospital
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
St. Joseph Mercy Oakland Hospital, Cancer Center
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Jackson Oncology Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Montana Cancer Institute Foundation
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Consultants in Medical Oncology and Hematology
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Reading Hospital Regional Cancer Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Kingsport Hematology-Oncology
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States
Facility Name
South Texas Oncology and Hematology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Cancer Outreach Associates
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20164695
Citation
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.
Results Reference
result
Links:
URL
http://journals.lww.com/journalppo/pages/articleviewer.aspx?year=2010&issue=02000&article=00013&type=abstract
Description
Published article in The Cancer Journal

Learn more about this trial

Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

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