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

Phase 3

Completed

• Conditions: Neoplasms, Unknown Primary
• Interventions: Drug: Gemcitabine; Drug: Etoposide; Drug: Paclitaxel; Drug: Irinotecan; Drug: Carboplatin

• Registration Number: NCT00193596
• Lead Sponsor: SCRI Development Innovations, LLC

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-09
• Study Completion: 2009-06
• Results First Submitted: 2013-01-14
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-22
• Last Update Submitted: 2013-03-22
• Results First Posted: 2013-05-03
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen B	Gemcitabine	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
Regimen A	Etoposide	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
Regimen A	Paclitaxel	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
Regimen A	Carboplatin	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
Regimen B	Irinotecan	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease

Trial Locations

Locations (31)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group; 🇺🇸 Mobile, Alabama, United States

Northeast Arkansas Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Tower Oncology; 🇺🇸 Beverly Hills, California, United States

Watson Clinic Center for Cancer Care and Research; 🇺🇸 Lakeland, Florida, United States

Mercy Hospital Miami; 🇺🇸 Miami, Florida, United States

Florida Hospital Cancer Institute; 🇺🇸 Orlando, Florida, United States

Phoebe Cancer Center; 🇺🇸 Albany, Georgia, United States

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

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