Irinotecan Study For Cervical Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136955
First received: August 25, 2005
Last updated: August 26, 2009
Last verified: July 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Cervical Neoplasms |
Drug: Irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
- Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) [ Time Frame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population) [ 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. ] [ Designated as safety issue: No ]
- Overall Survival (OS) and Time to Tumor Progression (ITT Population) [ 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. ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | June 2004 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: irinitecan/cisplatin
experimental arm consists of patients who receive irinotecan/cisplatin
|
Drug: Irinotecan
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136955
Locations
| Taiwan | |
| Pfizer Investigational Site | |
| Kaoshiung, Taiwan, 813 | |
| Pfizer Investigational Site | |
| Kwei-Shan County, TaoYuan,, Taiwan | |
| Pfizer Investigational Site | |
| Taichung, Taiwan | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 112 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00136955 History of Changes |
| Other Study ID Numbers: | XRP4174/2502, A5961083 |
| Study First Received: | August 25, 2005 |
| Results First Received: | May 7, 2009 |
| Last Updated: | August 26, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Pfizer:
|
Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Squamous Cell Uterine Cervical Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Irinotecan Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013