NCT00136955

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 25, 2009

Completed
Last Updated

June 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

August 25, 2005

Results QC Date

May 7, 2009

Last Update Submit

May 22, 2015

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)

    Tumor response according to RECIST.

    At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)

  • Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)

    Tumor response according to RECIST.

    At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)

Secondary Outcomes (2)

  • Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)

    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.

  • Overall Survival (OS) and Time to Tumor Progression (ITT Population)

    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.

Study Arms (1)

irinitecan/cisplatin

EXPERIMENTAL

experimental arm consists of patients who receive irinotecan/cisplatin

Drug: Irinotecan

Interventions

IrinotecanDRUG

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

irinitecan/cisplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Kwei-Shan County, TaoYuan,, Taiwan, Taiwan

Location

Pfizer Investigational Site

Taichung, Taiwan, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan, 112, Taiwan

Location

Pfizer Investigational Site

Kaoshiung, 813, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

June 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 19, 2015

Results First Posted

June 25, 2009

Record last verified: 2015-05

Locations

TW(5)