CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Iressadrug
Likely dose
Iressa (gefitinib) 250 mg orally once dailyAI-extracted
Key inclusion· 7
  • ✓Pathologically confirmed locoregional recurrence and/or metastatic squamous cell carcinoma of the skin not amenable to curative therapy (surgery or radiation)
  • ✓Evaluable and/or measurable disease per UICC/WHO criteria
  • ✓ECOG performance status 0-2
  • ✓Up to one prior chemotherapy regimen allowed
Key exclusion· 10
  • ✕Prior ZD1839 (Iressa) or other EGFR-inhibiting agents
  • ✕Other co-existing malignancies or malignancies diagnosed within last 3 years (except basal cell carcinoma or cervical cancer in situ)
  • ✕Unresolved chronic toxicity >CTC grade 2 from prior anticancer therapy
  • ✕Incomplete healing from previous oncologic or major surgery

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

Search/NCT00054691
NCT00054691Phase 2Completed
CompareCT.gov

A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

M.D. Anderson Cancer Center·interventional·Posted Feb 7, 2003·Updated Mar 13, 2015

In Brief

A Phase 2 clinical trial evaluating Iressa for Skin Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell cancer (SCC) of the skin. The safety of this drug will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Cancer
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2003
Enrollment StartMay 1, 2004
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 23.4 years ago

Interventions

Iressadrug

250 mg by mouth daily