Irinotecan Study For Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136955
First received: August 25, 2005
Last updated: August 26, 2009
Last verified: July 2009

August 25, 2005
August 26, 2009
June 2004
May 2008   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
the overall response rate
Complete list of historical versions of study NCT00136955 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
overall survival and time to progression
Not Provided
Not Provided
 
Irinotecan Study For Cervical Cancer
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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Cervical Neoplasms
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
Experimental: irinitecan/cisplatin
experimental arm consists of patients who receive irinotecan/cisplatin
Intervention: Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00136955
XRP4174/2502, A5961083
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP