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 recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01044420
First received: January 6, 2010
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Advanced Esophageal Carcinoma
Drug: mFOLFIRI
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: after each cycle of chemotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
  • response rate [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044420

Contacts
Contact: zhang xiaodong, MD 86-01-88196175 zxd0829@yahoo.com.cn
Contact: zhang xiaotian, MD 86-01-88196561 zhangxtxx@gmail.com

Locations
China, Beijing
Zhang Xiaodong Recruiting
Beijing, Beijing, China, 100142
Contact: zhang xiaodong, MD    86-10-88196175    zxd0829@yahoo.com.cn   
Sponsors and Collaborators
Peking University
Investigators
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
  More Information

No publications provided

Responsible Party: zhang xiaodong, Peking University, School of Oncology, Department of GI oncology
ClinicalTrials.gov Identifier: NCT01044420     History of Changes
Other Study ID Numbers: FOLFIRI-AEC2
Study First Received: January 6, 2010
Last Updated: January 6, 2010
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014