NCT00193596

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms, Unknown Primary

Interventions

Type	Name	Description
DRUG	Etoposide	50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
DRUG	Gemcitabine	1000 mg/m2 IV, days 1 and 8, in regimen B
DRUG	Irinotecan	1000 mg/m2 IV days 1 and 8 in regimen B
DRUG	Paclitaxel	200 mg/m2 by 1-hour IV infusion, day 1, regimen A
DRUG	Carboplatin	Area under the curve (AUC) 6.0 IV, day 1, regimen A

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-09-01
• Completion: 2009-06-01
• First posted: 2005-09-19
• Last updated: 2013-05-03
• Results posted: 2013-05-03

Locations

31 sites across 1 country: United States