mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044420
Recruitment Status : Unknown
Verified May 2009 by Peking University.
Recruitment status was:  Recruiting
First Posted : January 7, 2010
Last Update Posted : January 7, 2010
Information provided by:
Peking University

Brief Summary:
There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

Condition or disease Intervention/treatment Phase
Advanced Esophageal Carcinoma Drug: mFOLFIRI Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: mFOLFIRI Drug: mFOLFIRI
mFOLFIRI irinotecan 130-150mg/m2 iv d1 LV 200 mg/m2 iv 2h d1 5-FU 400 mg/m2 IV d1 5-FU 2.4-3 g/m2 CI 46-h repeat every 2 weeks

Primary Outcome Measures :
  1. overall survival [ Time Frame: 2 year ]
  2. adverse events [ Time Frame: after each cycle of chemotherapy ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 1year ]
  2. response rate [ Time Frame: every 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Having signed informed consent
  • Age 18 to 70 years old
  • Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
  • Unresectable recurrent or metastatic disease
  • Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
  • Karnofsky performance status ≥70
  • Life expectancy of ≥3 month
  • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  • ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  • Serum AKP < 2.5 times ULN (within 7 days before enrollment)
  • Serum creatinine <1.0 times ULN (within 7 days before enrollment)
  • Bilirubin level < 1.0 times ULN (within 7 days before enrollment)
  • WBC>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl(within 7 days before enrollment)
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃;
  • Good compliance

Exclusion Criteria:

  • More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
  • Known hypersensitivity to irinotecan
  • Only with Brain or bone metastasis
  • Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
  • No measurable lesions, eg. pleural fluid and ascites
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  • Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
  • Pregnancy or lactation period
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Chronic diarrhea
  • Mentally abnormal or disable cognition,including CNS metastasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044420

Contact: zhang xiaodong, MD 86-01-88196175
Contact: zhang xiaotian, MD 86-01-88196561

China, Beijing
Zhang Xiaodong Recruiting
Beijing, Beijing, China, 100142
Contact: zhang xiaodong, MD    86-10-88196175   
Sponsors and Collaborators
Peking University
Study Chair: shen lin, MD peking university, school of oncology, department of GI oncology
Principal Investigator: zhang xiaodong, MD Peking University, school of oncology, department of GI oncology

Responsible Party: zhang xiaodong, Peking University, School of Oncology, Department of GI oncology Identifier: NCT01044420     History of Changes
Other Study ID Numbers: FOLFIRI-AEC2
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: May 2009

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases