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

March 22, 2013 updated by: SCRI Development Innovations, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Northeast Alabama Regional Medical Center
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Northeast Arkansas Clinic
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Oncology
    • Florida
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Cancer Care and Research
      • Miami, Florida, United States, 33133
        • Mercy Hospital Miami
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Cancer Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Marietta, Georgia, United States, 30060
        • Wellstar Cancer Research
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Terrebonne General Medical Center
    • Maine
      • Portland, Maine, United States, 04101
        • Mercy Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy Oakland Hospital, Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Cancer Institute Foundation
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Consultants in Medical Oncology and Hematology
      • West Reading, Pennsylvania, United States, 19612
        • Reading Hospital Regional Cancer Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Kingsport Hematology-Oncology
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC
    • Texas
      • San Antonio, Texas, United States, 78258
        • South Texas Oncology and Hematology
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Etoposide
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
Other Names:
  • Toposar
  • Etopophos
Drug: Paclitaxel
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
Other Names:
  • Abraxane
Drug: Carboplatin
Area under the curve (AUC) 6.0 IV, day 1, regimen A
Other Names:
  • Paraplatin
Experimental: 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
Drug: Gemcitabine
1000 mg/m2 IV, days 1 and 8, in regimen B
Other Names:
  • Gemzar
Drug: Irinotecan
1000 mg/m2 IV days 1 and 8 in regimen B
Other Names:
  • Camptosar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time Frame: 24 months
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12 months
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Eli Lilly and Company
AstraZeneca
Pharmacia and Upjohn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI UNKPRI 12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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