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
18 Years
75 Years
Female
Uterine Cervical Neoplasms
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Outcome Time Frame:
At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Taiwan: Department of Health
Study ID:
XRP4174/2502
NCT ID:
NCT00136955
Start Date:
June 2004
Completion Date:
May 2008
Related Keywords:
- Uterine Cervical Neoplasms
- Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix
- Neoplasms
- Carcinoma, Squamous Cell
- Uterine Cervical Neoplasms
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