Irinotecan Study For Cervical Cancer

NCT ID: NCT00136955

Last Updated: 2015-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Uterine Cervical Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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irinitecan/cisplatin

experimental arm consists of patients who receive irinotecan/cisplatin

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

* Patients ever received cisplatin with total dose \> 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kwei-Shan County, TaoYuan,, Taiwan, Taiwan

Site Status

Pfizer Investigational Site

Taichung, Taiwan, Taiwan

Site Status

Pfizer Investigational Site

Taipei, Taiwan, Taiwan

Site Status

Pfizer Investigational Site

Kaoshiung, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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Other Identifiers

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A5961083

Identifier Type: -

Identifier Source: secondary_id

XRP4174/2502

Identifier Type: -

Identifier Source: org_study_id

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