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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Unk

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 Summary:

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.


Sponsor: SCRI Development Innovations, LLC

Current Primary Outcome: 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.


Original Primary Outcome: Progression free survival

Current Secondary Outcome: 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


Original Secondary Outcome:

  • Overall response rate
  • Overall survival
  • Overall toxicity


Information By: SCRI Development Innovations, LLC

Dates:
Date Received: September 12, 2005
Date Started: September 2003
Date Completion:
Last Updated: March 22, 2013
Last Verified: March 2013