Irinotecan Study For Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136955
• Other study ID #: XRP4174/2502
• Secondary ID: A5961083
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2005
• Last updated: May 22, 2015
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Kaoshiung
Taiwan	Pfizer Investigational Site	Kwei-Shan County, TaoYuan,
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)	Tumor response according to RECIST.	At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)	No
Primary	Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)	Tumor response according to RECIST.	At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)	No
Secondary	Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)	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.	No
Secondary	Overall Survival (OS) and Time to Tumor Progression (ITT Population)	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.	No

External Links

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