Irinotecan Study For Cervical Cancer

• ClinicalTrials.gov Identifier: NCT00136955
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Results First Posted: June 25, 2009
• Last Update Posted: June 19, 2015
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

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

Condition or disease	Intervention/treatment	Phase
Uterine Cervical Neoplasms	Drug: Irinotecan	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: June 2004
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   Tumor response according to RECIST.
2. 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) ]
   Tumor response according to RECIST.

Secondary Outcome Measures :

1. 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. ]
   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.
2. 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes 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

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:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• ClinicalTrials.gov Identifier: NCT00136955
• Other Study ID Numbers: XRP4174/2502; A5961083
• First Posted: August 29, 2005
• Results First Posted: June 25, 2009
• Last Update Posted: June 19, 2015
• Last Verified: May 2015

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:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Irinotecan; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents