CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Hycamtindrug
Likely dose
Topotecan 1.0 mg/m²/day on days 1–3 plus carboplatin AUC 5 on day 3, every 21 daysAI-extracted
Key inclusion· 7
  • Age 18 years or older
  • Diagnosis of ovarian cancer after primary therapy (relapsed disease)
  • ECOG performance status 0, 1, or 2
  • Adequate bone marrow function: leukocytes ≥4.0×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL
Key exclusion· 3
  • Known hypersensitivity to topotecan, topoisomerase-I inhibitors, or other study protocol medications
  • ECOG performance status greater than 2
  • Radiotherapy within the last 4 weeks

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

Search/NCT00170625
NCT00170625Phase 2Completed

Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

North Eastern German Society of Gynaecological Oncology·interventional·Posted Sep 15, 2005·Updated Nov 12, 2024

In Brief

A Phase 2 clinical trial evaluating Hycamtin for Ovarian Cancer. Completed, enrolled 28 participants.

Detailed Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJun 1, 2004
Primary CompletionAug 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.8 years ago

Interventions

Hycamtindrug

Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d