CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Irinotecandrug
Likely dose
Irinotecan 60 mg/m² on days 1, 8, and 15 plus cisplatin 60 mg/m² on day 1 (weekly)AI-extracted
Key inclusion· 3
  • ✓Histologically documented advanced or recurrent squamous cell carcinoma of uterine cervix
  • ✓Measurable lesion(s) without previous radiation therapy
  • ✓Prior concurrent or (neo)adjuvant chemotherapy allowed if ≥6 months since completion and recurrence documented
Key exclusion· 2
  • ✕Prior primary chemotherapy for cervical cancer other than concurrent or (neo)adjuvant therapy mentioned in inclusion criteria
  • ✕Prior cisplatin dose >300 mg/m² with radiotherapy or local treatment delivered to the target lesion

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

Search/NCT00136955
NCT00136955Phase 2Completed
CompareCT.gov

An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan Plus Cisplatin As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix

Pfizer·interventional·Posted Aug 29, 2005·Updated Jun 19, 2015

In Brief

A Phase 2 clinical trial evaluating Irinotecan for Uterine Cervical Neoplasms. Completed, enrolled 41 participants across 5 sites.

Detailed Summary

The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Cervical Neoplasms
CountriesTaiwan
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2005
Enrollment StartJun 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.8 years ago

Interventions

Irinotecandrug

An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan (60mg/sqm, D1, 8, 15) Plus Cisplatin (60mg/sqm, D1) As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix