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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Cisplatin,P-HDFL

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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)]/[sereum 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cisplatin,P-HDFL; 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.

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.; Other Names: fluorouracil; Abilatin、Platamine、Platinex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From the first date of chemotherapy to death or last contact.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: cisplatin; recurrence; Cervical cancer; metastasis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Cisplatin; Fluorouracil
• Other Study ID Numbers: 201211032RIC