Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a 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: NCT01051765
Recruitment Status : Unknown
Verified May 2009 by Peking University.
Recruitment status was:  Recruiting
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
Information provided by:
Peking University

Brief Summary:
Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

Condition or disease Intervention/treatment Phase
Advanced Esophageal Squamous Carcinoma Drug: irinotecan/cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
Study Start Date : August 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: irinotecan/cisplatin
irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks
Drug: irinotecan/cisplatin
irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks

Primary Outcome Measures :
  1. overall survival [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. PFS [ Time Frame: 1year ]
  2. response rate [ Time Frame: 1.5 months ]
  3. adverse events [ Time Frame: 2 year ]
  4. polymorphism of UGT1A [ Time Frame: 2 year ]

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, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
  • 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:

  • previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
  • 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): NCT01051765

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

Responsible Party: zhang xiaodong, Peking University, School of Oncology, Department of GI oncology Identifier: NCT01051765     History of Changes
Other Study ID Numbers: IP-AEC1
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: May 2009

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action