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Irinotecan Study For Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00136955
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : June 25, 2009
Last Update Posted : June 19, 2015
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: Irinotecan Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2004
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136955


Locations
Taiwan
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00136955     History of Changes
Other Study ID Numbers: XRP4174/2502
A5961083
First Posted: August 29, 2005    Key Record Dates
Results First Posted: June 25, 2009
Last Update Posted: June 19, 2015
Last Verified: May 2015

Keywords provided by Pfizer:
Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Irinotecan
Cisplatin
Camptothecin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action