CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
topotecan hydrochloridedrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed carcinoma of the cervix (squamous cell or nonsquamous cell)
  • ✓Persistent or recurrent disease with documented disease progression
  • ✓Measurable disease: at least 1 lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • ✓Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent cervical cancer
Key exclusion· 7
  • ✕No prior topotecan therapy
  • ✕More than 1 prior cytotoxic chemotherapy regimen
  • ✕Eligible for a higher priority GOG protocol (active phase III GOG protocol for same patient population)
  • ✕Sensory or motor neuropathy grade 2 or higher

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

Search/NCT00087126
NCT00087126Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix

Gynecologic Oncology Group·interventional·Posted Jul 12, 2004·Updated Jan 8, 2019

In Brief

A Phase 2 clinical trial evaluating topotecan hydrochloride for Cervical Cancer. Completed, enrolled 27 participants across 27 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2004
Enrollment StartFeb 1, 2005
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 22.0 years ago

Interventions

topotecan hydrochloridedrug