CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 198 enrolled
Drug / intervention
Etoposide +4 moredrug
Likely dose
Regimen A: Paclitaxel 200 mg/m2 IV day 1 + Carboplatin AUC 6.0 IV day 1 + Etoposide 50-100 mg PO days 1 and 10, followed by IRESSA; Regimen B: Gemcitabine 1000 mg/m2 IV days 1 and 8 + Irinotecan 1000 mg/m2 IV days 1 and 8, followed by IRESSAAI-extracted
Key inclusion· 5
  • ✓Biopsy-proven metastatic carcinoma of unknown primary site
  • ✓Able to perform activities of daily living with minimal assistance
  • ✓No previous treatment with any systemic therapy
  • ✓Measurable or evaluable disease
Key exclusion· 6
  • ✕Age less than 18 years
  • ✕Uncontrolled brain metastases and meningeal involvement
  • ✕Other uncontrolled malignancies
  • ✕Recent history of significant cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00193596
NCT00193596Phase 3Completed
CompareCT.gov

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

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated May 3, 2013

In Brief

A Phase 3 clinical trial evaluating Etoposide, Gemcitabine, and 3 other interventions for Neoplasms, Unknown Primary. Completed, enrolled 198 participants across 31 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Unknown Primary
CountriesUnited States
CollaboratorsAstraZeneca, Pharmacia and Upjohn, Eli Lilly and Company

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartSep 1, 2003
Primary CompletionSep 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

Etoposidedrug

50 mg alternating with 100 mg PO, days 1 and 10 in regimen A

Gemcitabinedrug

1000 mg/m2 IV, days 1 and 8, in regimen B

Irinotecandrug

1000 mg/m2 IV days 1 and 8 in regimen B

Paclitaxeldrug

200 mg/m2 by 1-hour IV infusion, day 1, regimen A

Carboplatindrug

Area under the curve (AUC) 6.0 IV, day 1, regimen A