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A Randomized Phase II Clinical Trial of an Adenovirus-mediated Endostatin Gene (E10A) Combined With Cisplatin and Paclitaxel in Patients With Head and Neck Cancer


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Head and Neck Squamous Carcinoma, Nasopharyngeal Carcinoma

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Trial Information

A Randomized Phase II Clinical Trial of an Adenovirus-mediated Endostatin Gene (E10A) Combined With Cisplatin and Paclitaxel in Patients With Head and Neck Cancer


Inclusion Criteria:



- histologically or cytologically confirmed recurrent or metastatic head and neck
squamous carcinoma or nasopharyngeal carcinoma

- the tumor was amenable to direct injection and measurement ( > 2 cm)

- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- a life expectancy over three months

- the absence of serious medical or psychiatric disorders

- serum creatinine < 1.5 mg/dL; WBC count >3,000/mm3, platelet count > 80,000/mm3,
hemoglobin > 8 g/dL; total bilirubin value < 1.5 times the upper limit of normal
[ULN], ALT level < 2.5 times ULN, AST < 2.5 times ULN.

Exclusion Criteria:

- pregnant or breast feeding

- a history of brain metastases or a primary brain tumor

- a history of hemorrhagic diathesis

- a history of corticosteroids or immunosuppressives use within four weeks of study
entry

- a history of immune deficiency disorder or organ transplant

- has evidence of active adenovirus infection or uncontrolled infection

- received any chemotherapy or radiotherapy within four weeks of study entry

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor response confirmed by CT or MRI

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Wenqi Jiang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

TG0717E10A

NCT ID:

NCT00634595

Start Date:

March 2008

Completion Date:

December 2010

Related Keywords:

  • Head and Neck Squamous Carcinoma
  • Nasopharyngeal Carcinoma
  • clinical trial
  • randomized
  • Endostatin
  • gene therapy
  • head and neck cancer
  • head and neck squamous carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Nasopharyngeal Neoplasms

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