CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
topotecan hydrochloride +1 moredrug
Likely dose
Topotecan (IV) and 7-hydroxystaurosporine/UCN-01 (IV) — specific doses not stated in available textAI-extracted
Key inclusion· 5
  • Histologically confirmed extensive stage SCLC that is incurable but amenable to chemotherapy treatment
  • Measurable disease per RECIST; must have measurable disease outside radiation field or progression post-radiation
  • Relapsed or progressed ≥3 months after completing ONLY first-line platinum-based chemotherapy (chemo-sensitive disease)
  • Completed prior chemotherapy ≥3 months before study entry; surgery/radiotherapy ≥4 weeks before entry; recovered from prior therapy toxicities; <40% bone marrow radiated
Key exclusion· 9
  • Prior therapy with topoisomerase I inhibitors (topotecan or irinotecan)
  • Other chemotherapy regimens besides first-line platinum-based chemotherapy
  • Concurrent investigational agents or concurrent radiation therapy during study treatment
  • Uncontrolled/symptomatic CNS metastases

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

Search/NCT00098956
NCT00098956Phase 2Completed

A Phase II Study of UCN-01 in Combination With Topotecan in Patients With SCLC Who Relapsed or Progressed &gt;= 3 Months After Completing First-Line Platinum-Based Chemotherapy

National Cancer Institute (NCI)·interventional·Posted Dec 9, 2004·Updated Jul 23, 2018

In Brief

A Phase 2 clinical trial evaluating topotecan hydrochloride and 7-hydroxystaurosporine for Extensive Stage Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also increase the effectiveness of topotecan by making tumor cells more sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2004
Enrollment StartJan 1, 2005
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 21.6 years ago

Interventions

topotecan hydrochloridedrug

Given IV

7-hydroxystaurosporinedrug

Given IV