Irinotecan Study For Cervical Cancer

Sponsor
Pfizer
Study ID
NCT00136955
Phase
PHASE2
Status
Completed

Conditions

  • Uterine Cervical Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — 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

Study Details

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 Dates

Start date
Jun 30, 2004
Status verified
May 2015
Primary completion
May 31, 2008
Completion
May 31, 2008

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinitecan/cisplatin
    experimental arm consists of patients who receive irinotecan/cisplatin

Primary Outcome Measure

Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) [ Time Frame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment) ]

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