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

NCT02207660 | Completed DMC

• 1 other identifier: 201211032RIC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Keywords

cisplatin; Cervical cancer; metastasis; recurrence

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the first date of chemotherapy to death or last contact.

  5 years

Secondary Outcomes (1)

• Progression-free survival

  5 years

Study Arms (1)

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

Interventions

Cisplatin,P-HDFL DRUG

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.

Also known as: Abilatin、Platamine、Platinex, fluorouracil

Cisplatin,P-HDFL

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chi-An Chen, MD

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: August 4, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

TW (1)