Cisplatin Plus One-Day 24-hour Infusion of High-Dose 5-Fluorouracil for Stage IVB, Recurrent or Metastatic Carcinoma of the Uterine Cervix

Cervical Cancer Clinical Trial

Official title:

Cisplatin Plus One Day 24 Hour Infusion of High-Dose 5-Fluorouracil for Stage IVB, Recurrent or Metastatic Carcinoma of the Uterine Cervix.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207660
• Other study ID #: 201211032RIC
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: February 3, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Objectives: To evaluate the effectiveness and toxicity of the combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.

Methods: The medical records of all patients with stage IVB, recurrent or metastatic cervical cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at National Taiwan University Hospital were reviewed.

Expected results: Investigators will identify the effectiveness and toxicity of the combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.

Description:

The medical records for all patients with advanced, metastatic or recurrent cervical cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at National Taiwan University Hospital were reviewed. Recurrences were confirmed by histopathologic examinations. Cases of recurrent cervical cancer, who undergoing salvage surgery and receiving P-HDFL as adjuvant therapy, were excluded from this study. The general principles for patients schedule for P-HDFL regimen treatment were as followings: patients must have had white cell count > 3000/mm3, platelet count > 100000/mm3, a normal serum creatinine (≦1.5 mg/dL) or a measured creatinine clearance ([urine creatinine level (mg/dL) X 24-hr urine amount (mL)]/[serum creatinine level (mg/dL) X 1,440 min]) of ≧ 40 mL/min [12,15], total bilirubin ≦ 2 mg/dL, and transaminase (≦3X the upper normal limits). Also, patients needed to have measurable disease by radiographic studies (plain X-ray, CT or MRI scans), no serious active underlying medical issues, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. The ethical approval for this retrospective study was obtained from our research ethics committee in this hospital.

The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2 intravenous 24-hour infusion on Day 1. Normal saline hydration (≧1000 mL), dexamethasone, and antiemetics (ondansetron or granisetron) were given prophylactically before each dose of cisplatin.

Physical examination, survey of adverse reactions and hemogram checkup of patients were performed before administering each dose of the P-HDFL treatment. Tumor response and toxicity were evaluated according to the World Health Organization criteria [16]. A complete response (CR) was defined as the disappearance of all measurable disease for at least 4 weeks. A partial response (PR) was defined as a 50% or more reduction in the products of each measurable lesion for at least 4 weeks. Progressive disease (PD) was defined as a 25% or more increase in the size of one or more measurable lesions or the appearance of new lesions. Stable disease (SD) was defined as any condition not meeting any the above criteria.

Progression-free survival was measured from the first date of chemotherapy to the date of documented disease progression, death of other causes or last contact. Overall survival was measured from the first date of chemotherapy to death or last contact. Progression-free survival and overall survival were estimated by using the method of Kaplan-Meier.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• all patients with stage IVB, recurrent or metastatic cervical cancer who were treated with P-HDFL

Exclusion Criteria:

• Cases of recurrent cervical cancer, who undergoing salvage surgery and receiving P-HDFL as adjuvant therapy, were excluded from this study.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Cisplatin,P-HDFL
The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2 intravenous 24-hour infusion on Day 1. Normal saline hydration (?1000 mL), dexamethasone, and antiemetics (ondansetron or granisetron) were given prophylactically before each dose of cisplatin.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From the first date of chemotherapy to death or last contact.	5 years	No
Secondary	Progression-free survival	From the first date of chemotherapy to the date of documented disease progression, death of other causes or last contact.	5 years	No