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A Phase II Study of Endostar, Paclitaxel/Carboplatin and Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Phase II Study of Endostar, Paclitaxel/Carboplatin and Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer


Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation
therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours
d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min
weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5
mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.


Inclusion Criteria:



- Histologically proven non-small cell lung cancer (squamous cell carcinoma,
adenocarcinoma, large cell carcinoma and etc)

- Presence of measurable disease by RECIST

- stage IIIA or IIIB, non-resectable

- ECOG performance status 0-1

- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic
therapy .Patients must sign an informed consent indicating that they are aware of the
.investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

- Carcinoid tumor, small cell carcinoma of lung

- Patients with any distant metastasis

- History of another malignancy except cured basal cell carcinoma of skin and cured
carcinoma in-situ of uterine cervix

- Any other morbidity or situation with contraindication for radiotherapy (e.g. active
infection, myocardial infarction preceding 6 months, symptomatic heart disease
including unstable angina, congestive heart failure or uncontrolled arrhythmias,
immunosuppressive treatment)

- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days
before the first administration) and pregnant women

- Women and men of childbearing potential who have no willing of employing adequate
contraception Tumor EGFR wild

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 rate

Outcome Description:

Response was analyzed according to the RECIST system, based on CT scans.

Outcome Time Frame:

1 month after treatment.

Safety Issue:

Yes

Principal Investigator

Shenglin Ma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Ethics Committee

Study ID:

ZhejiangCH03

NCT ID:

NCT01158144

Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Locally advanced
  • Radiotherapy
  • Concomitant Chemotherapy
  • Endostar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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