Irinotecan Study For Cervical Cancer

May 22, 2015 updated by: Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaoshiung, Taiwan, 813
        • Pfizer Investigational Site
      • Kwei-Shan County, TaoYuan,, Taiwan
        • Pfizer Investigational Site
      • Taichung, Taiwan
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented
  • Having measurable lesion(s), without previous radiation therapy.

Exclusion Criteria:

  • Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria).
  • Patients ever received cisplatin with total dose > 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: irinitecan/cisplatin
experimental arm consists of patients who receive irinotecan/cisplatin
Drug: Irinotecan
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Time Frame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Tumor response according to RECIST.
At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
Time Frame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Tumor response according to RECIST.
At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)
Time Frame: Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.
TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.
Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.
Overall Survival (OS) and Time to Tumor Progression (ITT Population)
Time Frame: Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.
TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.
Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP4174/2502
  • A5961083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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