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Completed

NCT Number: NCT02023593

FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.

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Key information

Conditions

Advanced Esophageal Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFIRI

Drug

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.

Other names: Irinotecan, Leucovorin, 5-Fluorouracil

Primary outcomes

  1. Disease control rate

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Overall survival

    Time frame: From the date of first drug administration until the date of death, assessed up to 60months

  2. Adverse events

    Time frame: Each follow up visit, assessed up to 24 weeks

    Safety profile will be assessed using the NCI CTCAE version 3.0

  3. Progression free survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yuhong Li

Other

Registry information

Official study title

Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma

Important dates

Study start
2012
Primary completion
2019
Study completion
2022
First posted
Dec 30, 2013
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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