Irinotecan Study For Cervical Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00136955

Purpose

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	Intervention	Phase
Uterine Cervical Neoplasms	Drug: Irinotecan	Phase II

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

The overall response rate [ Time Frame: end of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Safety [ Time Frame: Duration of trial ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	June 2004
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
irinitecan/cisplatin: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136955

Locations

Taiwan
Pfizer Investigational Site
Kwei-Shan County, TaoYuan,, Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 112
Pfizer Investigational Site
TAIPEI, Taiwan
Pfizer Investigational Site
Kaoshiung, Taiwan, 813
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
TAIPEI, Taiwan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	XRP4174/2502, A5961083
Study First Received:	August 25, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00136955
Health Authority:	Taiwan: Department of Health

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

Study placed in the following topic categories:

Squamous cell carcinoma
Irinotecan
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Recurrence
Carcinoma
Epidermoid carcinoma
Uterine Cervical Neoplasms

Genital Diseases, Female
Uterine Cervical Diseases
Cisplatin
Carcinoma, squamous cell
Uterine Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009