Clinical trial NCT02023593: FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma
Official title: Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Esophageal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Disease control rate
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: From the date of first drug administration until the date of death, assessed up to 60months
measure: Adverse events
timeFrame: Each follow up visit, assessed up to 24 weeks
measure: Progression free survival
timeFrame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Yuhong, Ph D
role: PRINCIPAL_INVESTIGATOR
References: