Cisplatin Plus One-Day 24-hour Infusion of High-Dose 5-Fluorouracil for Stage IVB, Recurrent or Metastatic Carcinoma of the Uterine Cervix
Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Cancer
Intervention: Cisplatin,P-HDFL (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s): Chi-An Chen, MD, Study Chair, Affiliation: National Taiwan University Hospital
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.
Clinical Details
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.
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Overall survival
Secondary outcome: Progression-free survival
Detailed 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
National Taiwan University Hospital, Taipei, Taiwan
Additional Information
Starting date: July 2014
Last updated: February 3, 2015
|