At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 19 enrolled

Drug / intervention

Topotecan +1 moredrug

Likely dose

Topotecan 2 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00317772

NCT00317772Phase 2Completed

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A Phase I/II Study of Weekly Topotecan and Gefitinib (Iressa) in Patients With Platinum-Resistant Ovarian, Peritoneal, of Fallopian Tube Cancer

M.D. Anderson Cancer Center·interventional·Posted Apr 25, 2006·Updated Feb 7, 2022

In Brief

A Phase 2 clinical trial evaluating Topotecan and Gefitinib for Ovarian Cancer and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purposes of this study are: 1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) weekly of topotecan in combination with standard dose gefitinib in patients with relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are epidermal growth factor receptor (EGF-R) positive (\>/= 1+). 2. To determine the response rate and response duration in this patient population treated with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in combination with standard dose gefitinib, given by way of the mouth (PO) daily.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOvarian Cancer, Peritoneal Neoplasms, Fallopian Tube Cancer

CountriesUnited States

CollaboratorsAstraZeneca, GlaxoSmithKline

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2004

First PostedApr 2006

Primary CompletionNov 2020

TodayJul 2026

First PostedApr 25, 2006

Enrollment StartSep 2, 2004

Primary CompletionNov 4, 2020

TodayJul 2, 2026

Enrollment to primary: 16.2 yearsPosted 20.2 years ago

Interventions

Topotecandrug

Phase I Starting Dose: 2 mg/m\^2 by vein Weekly Over 30 Minutes on Days 1, 8, and 15. Phase II: MTD dose from Phase I by vein weekly on Days 1, 8, and 15.

Gefitinibdrug

Phase I: 250 mg by mouth daily for 28 Days. Phase II: 250 mg by mouth daily for 28 Days.