Back to resultsIrinotecan Study For Cervical Cancer
Primary Purpose
Uterine Cervical Neoplasms
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
irinitecan/cisplatin
Arm Description
experimental arm consists of patients who receive irinotecan/cisplatin
Outcomes
Primary Outcome Measures
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Tumor response according to RECIST.
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
Tumor response according to RECIST.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00136955
Brief Title
Irinotecan Study For Cervical Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
irinitecan/cisplatin
Arm Type
Experimental
Arm Description
experimental arm consists of patients who receive irinotecan/cisplatin
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
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
Primary Outcome Measure Information:
Title
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Description
Tumor response according to RECIST.
Time Frame
At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Title
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
Description
Tumor response according to RECIST.
Time Frame
At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)
Description
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.
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.
Title
Overall Survival (OS) and Time to Tumor Progression (ITT Population)
Description
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.
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kaoshiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kwei-Shan County, TaoYuan,
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=XRP4174/2502&StudyName=Irinotecan%20Study%20For%20Cervical%20Cancer
Description
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Irinotecan Study For Cervical Cancer
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