Clinical trial NCT00136955: Irinotecan Study For Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
timeFrame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
measure: Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
timeFrame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Secondary outcomes:
measure: Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)
timeFrame: 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.
measure: Overall Survival (OS) and Time to Tumor Progression (ITT Population)
timeFrame: 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.
Other outcomes:
Locations:
city: Kaoshiung
country: Taiwan
facility: Pfizer Investigational Site
city: Kwei-Shan County, TaoYuan,
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: