Irinotecan Study For Cervical Cancer

Phase 2

Completed

• Conditions: Uterine Cervical Neoplasms
• Interventions: Drug: Irinotecan

• Registration Number: NCT00136955
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-05-07
• Results First Submitted QC: 2009-05-07
• Results First Posted: 2009-06-25
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
irinitecan/cisplatin	Irinotecan	experimental arm consists of patients who receive irinotecan/cisplatin

Primary Outcome Measures

Name	Time	Method
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)	At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)	Tumor response according to RECIST.
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)	At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)	Tumor response according to RECIST.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taipei, Taiwan