Irinotecan Study For Cervical Cancer

NCT00136955CompletedPHASE2INTERVENTIONAL

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

Key Facts

Lead Sponsor

Pfizer

Enrollment

41

Start Date

2004-06-01

Completion Date

2008-05-01

Study Type

INTERVENTIONAL

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

Interventions

Irinotecan

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Tumor response according to RECIST.

Time frame: 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.

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

Secondary Outcomes

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

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.

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.

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

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.

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.

Locations

Pfizer Investigational Site, Kwei-Shan County, TaoYuan,, Taiwan

Pfizer Investigational Site, Taichung, Taiwan

Pfizer Investigational Site, Taipei, Taiwan

Pfizer Investigational Site, Kaoshiung, Taiwan

Pfizer Investigational Site, Taipei, Taiwan

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Irinotecan Study For Cervical Cancer