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

NCT01044420 | Unknown Phase 2

• 1 other identifier: FOLFIRI-AEC2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Esophageal Carcinoma

Outcome Measures

Primary Outcomes (2)

• overall survival

  2 year

• adverse events

  after each cycle of chemotherapy

Secondary Outcomes (2)

• progression-free survival

  1year

• response rate

  every 6 weeks

Study Arms (1)

mFOLFIRI

EXPERIMENTAL

Drug: mFOLFIRI

Interventions

mFOLFIRI DRUG

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

mFOLFIRI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Zhang Xiaodong

Beijing, Beijing Municipality, 100142, China

RECRUITING

Study Officials

• shen lin, MD

  peking university, school of oncology, department of GI oncology

  STUDY CHAIR

• zhang xiaodong, MD

  Peking University, school of oncology, department of GI oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang xiaodong, MD

CONTACT

86-01-88196175; zxd0829@yahoo.com.cn

zhang xiaotian, MD

CONTACT

86-01-88196561; zhangxtxx@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: May 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: January 7, 2010

Record last verified: 2009-05

Locations

CN (1)