Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a 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:
NCT01051765
First received: January 19, 2010
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Advanced Esophageal Squamous Carcinoma
Drug: irinotecan/cisplatin
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
Official Title: Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

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 ]

Secondary Outcome Measures:
  • PFS [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • polymorphism of UGT1A [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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, 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
  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: NCT01051765

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
  More Information

No publications provided

Responsible Party: zhang xiaodong, Peking University, School of Oncology, Department of GI oncology
ClinicalTrials.gov Identifier: NCT01051765     History of Changes
Other Study ID Numbers: IP-AEC1
Study First Received: January 19, 2010
Last Updated: January 19, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Irinotecan
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014