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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

Phase 3
18 Years
Not Enrolling
Neoplasms, Unknown Primary

Thank you

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:


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:


Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2003

Completion Date:

June 2009

Related Keywords:

  • Neoplasms, Unknown Primary
  • Neoplasms, Unknown Primary
  • Neoplasms
  • Carcinoma
  • Neoplasms, Unknown Primary



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