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Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer

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ClinicalTrials.gov Identifier: NCT01336049
Recruitment Status : Unknown
Verified March 2011 by Peking University.
Recruitment status was:  Recruiting
First Posted : April 15, 2011
Last Update Posted : April 15, 2011
Information provided by:
Peking University

Brief Summary:
Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before,the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/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
Esophageal Squamous Cell Cancer Drug: Nimotuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
Study Start Date : March 2011
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nimotuzumab Drug: Nimotuzumab
Nimotuzumab 200mg/week

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 weeks ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Secondary Outcome Measures :
  1. overall survival of all participants [ Time Frame: 2 years ]
    OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost

  2. progression free survival [ Time Frame: 1 year ]
    the follow-up visit of PFS will be performed every 2 cycles

  3. adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    any adverse event will be record on CRF for safety control

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Having signed informed consent
  • Age 18 to 75 years old
  • Histologically confirmed esophageal squamous carcinoma, Unresectable recurrent or metastatic disease,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months,recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of paclitaxel as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
  • Sex is not limited
  • 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 ≥80
  • Life expectancy of ≥ 3 month
  • WBC > 4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet > 100,000/mm3, Hb > 10g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.0 times ULN
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃;
  • Normal ECG and heart function
  • Fertile patients must use effective contraception
  • 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 Nimotuzumab,Paclitaxel,Cisplatin
  • 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
  • Suffer from severe heart disease or disease with other important organs
  • Chronic diarrhea or renal dysfunction
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01336049

Contact: xiaodong zhang, MD 86-01-88196175 zxd0829@yahoo.com.cn
Contact: jifang gong, MD 86-01-88196088 gongjifang@gmail.com

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

Responsible Party: zhang xiaodong, Peking University, School of Oncology, Department of GI oncology
ClinicalTrials.gov Identifier: NCT01336049     History of Changes
Other Study ID Numbers: N+TP-AEC3
First Posted: April 15, 2011    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action