Advanced Esophageal Carcinoma
Conditions
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.
Interventions
DRUGFOLFIRI
Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
Sponsors
Yuhong Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From the date of first drug administration until the date of death, assessed up to 60months | — |
| Adverse events | Each follow up visit, assessed up to 24 weeks | Safety profile will be assessed using the NCI CTCAE version 3.0 |
| Progression free survival | 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 | — |
Countries
China
Outcome results
None listed