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
Recruitment status was Recruiting
Sponsor:
Peking University
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
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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
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 Carcinoma, Squamous Cell Neoplasms, Squamous Cell Esophageal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Irinotecan Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013