NCT01336049

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

April 15, 2011

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

March 29, 2011

Last Update Submit

April 14, 2011

Conditions

Esophageal Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

    6 weeks

Secondary Outcomes (3)

  • overall survival of all participants

    2 years

  • progression free survival

    1 year

  • adverse events

    participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (1)

Nimotuzumab

EXPERIMENTAL
Drug: Nimotuzumab

Interventions

NimotuzumabDRUG

Nimotuzumab 200mg/week

Nimotuzumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaodong Zhang

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

xiaodong zhang, MD

CONTACT

86-01-88196175zxd0829@yahoo.com.cn

jifang gong, MD

CONTACT

86-01-88196088gongjifang@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 15, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Last Updated

April 15, 2011

Record last verified: 2011-03

Locations

CN(1)