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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neoplasms, Unknown Primary

Intervention / Treatment
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* Drug: Etoposide
* Drug: Gemcitabine
* Drug: Irinotecan
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br>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<br>* 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A<br>* Other names: Toposar;Drug: Paclitaxel<br>* 200 mg/m2 by 1-hour IV infusion, day 1, regimen A<br>* Other names: Abraxane;Drug: Carboplatin<br>* Area under the curve (AUC) 6.0 IV, day 1, regimen A<br>* Other names: Paraplatin;|
| Experimental: Regimen B<br>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<br>* 1000 mg/m2 IV, days 1 and 8, in regimen B<br>* Other names: Gemzar;Drug: Irinotecan<br>* 1000 mg/m2 IV days 1 and 8 in regimen B<br>* Other names: Camptosar;|

What is the study measuring?
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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 | 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 | Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Unknown Primary