Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154700

Enrollment

Registered

2005-09-12

Start date

2001-01-31

Completion date

2005-07-31

Last updated

2005-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Combination,Chemotherapy,Esophageal Cancer

Brief summary

The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy.

Detailed description

Interventions

DRUGPaclitaxel,Cisplatin,5-Fu,Folic Acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or metastasis Measurable disease (\> 1 X 1 cm) by CXR, CT scan or MRI,Age \> 18, KPS \> 60% , Cre \< 1.5mg/dl, AST/ALT \< 3.5 X N, Bil \< 2.0mg/dl WBC \> 4,000/mm3, ANC \> 2,000/ mm3, Plt \> 100,000/mm3

Exclusion criteria

* Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except \> 2 months)

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Overall survival	—
Progression-free survival	—
Toxicity	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026