FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma
Conditions
Advanced Esophageal Carcinoma
Conditions: official terms
Carcinoma - Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FOLFIRI
Type: Drug
Overall Status
Recruiting
Summary
This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.
Detailed Description
Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients have provided a signed Informed Consent Form

- Karnofsky score ≥70

- Age: 18-75 years old

- Histologically confirmed diagnosis of advanced esophageal carcinoma

- Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy

- Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria

- Life expectancy ≥ 3 months

- Patient has adequate bone marrow and organ function

- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L

- Platelets ≥ 75 x 109/L

- Hemoglobin ≥ 9.0 g/dL

- Patient has adequate liver function

- AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)

- Serum bilirubin ≤ 2 x ULN

- Creatinine ≤ 1.5 times ULN

- Good compliance

Exclusion Criteria:

- Pregnant or lactating women

- Brain metastasis or only with bone metastasis.

- Patients with severe infection or active peptic ulcer which need treatment

- Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases

- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ

- Psychiatric illness that would prevent the patient from giving informed consent

- Patient is concurrently using other approved or investigational antineoplastic agent
Location
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Li Yuhong, Ph D - liyh@sysucc.org.cn
Start Date
March 2012
Completion Date
December 2015
Sponsors
Yuhong Li
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page