CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
OSI-774drug
Likely dose
Dose not specified in provided textAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed advanced RCC (papillary RCC only if strong 2-3+ EGFR expression by immunohistochemistry)
  • ✓Disease refractory to IL-2 or IFN-based therapy, OR newly diagnosed and not appropriate for IL-2 treatment
  • ✓Measurable disease: ≥20 mm on conventional imaging or ≥10 mm on spiral CT
  • ✓Age >18 years
Key exclusion· 9
  • ✕Active malignancy (other than RCC) within past 3 years, except nonmelanomatous skin cancer or in situ breast/cervical cancer
  • ✕Known brain metastases
  • ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C)
  • ✕Prior EGFR-targeting therapies

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

Search/NCT00045487
NCT00045487Phase 2Completed
CompareCT.gov

A Phase II, Pharmacokinetic And Biologic Correlative Study of OSI-774, An EGFR Tyrosine Kinase Inhibitor, In Patients With Advanced Renal Cell Carcinoma

The University of Texas Health Science Center at San Antonio·interventional·Posted Jan 27, 2003·Updated Jan 27, 2014

In Brief

A Phase 2 clinical trial evaluating OSI-774 for Kidney Cancer. Completed, enrolled 41 participants across 1 site.

Detailed Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2002
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 23.4 years ago

Interventions

OSI-774drug

OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.