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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01336049
First received: March 29, 2011
Last updated: April 14, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Esophageal Squamous Cell Cancer
Drug: Nimotuzumab
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: Nimotuzumab Plus Paclitaxel and 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:
  • Objective response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation


Secondary Outcome Measures:
  • overall survival of all participants [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the follow-up visit of PFS will be performed every 2 cycles

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


Estimated Enrollment: 70
Study Start Date: March 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nimotuzumab Drug: Nimotuzumab
Nimotuzumab 200mg/week

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01336049

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

Locations
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
  More Information

No publications provided

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
Study First Received: March 29, 2011
Last Updated: April 14, 2011
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
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 26, 2014