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Irinotecan Study For Cervical Cancer

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NCT00136955

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kaoshiung, , 813 Taiwan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Uterine Cervical Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00136955
Pfizer
Completed
Irinotecan Study For Cervical Cancer

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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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00136955
XRP4174/2502
A5961083
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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