Know Cancer

or
forgot password

A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer


Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS) Recent studies have shown that
celecoxib has antitumor activity, and may increase the tumor sensitivity to radiation.
Furthermore, evidence has shown the safety and efficiency of celecoxib in some phase I/II
studies. The purposes of this study are to examine the effects of a new combination of
celecoxib (Celebrex®) and cisplatin/etoposide (EP regimen), with concurrent thoracic
radiotherapy on unresectable stage III NSCLC patients; and to examine biomarkers to predict
response to the treatment. Because of poor survival of patients with unresected locally
advanced NSCLC, the efficiency of celecoxib plus concurrent EP chemoradiotherapy need to be
further investigated.


Inclusion Criteria:



- • 18-70 years old, male or female

- Histological or cytological evidence of NSCLC.

- Unresectable Stage III NSCLC.

- Karnofsky score: at least 70.

- Estimated survival: at least 6 months

- Not receiving radiotherapy or combined modality therapy to treat another
malignancy.

- No history of active gastric ulcer, active GI bleeding, or renal failure.

- No severe hypertension, cardiac disease, or diabetes mellitus

- Normal blood routine and chemical tests

- Patients or guardian must be informed of the investigational nature of this
study and must sign and give written informed consent in accordance with
institutional and federal guidelines.

Exclusion Criteria:

- • Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer

- Extensive distant metastases

- Pregnancy or in lactation

- Allergic to Sulfonamides, NSAIDS or Celebrex

- Routine use of NSAIDS such as high dose of Aspirin

- History of cardiovascular diseases including: myocardial infraction, angina,
coronary angioplasty, congestive heart failure, stroke, or coronary bypass
surgery in the last 6 months.

- Abnormal coagulation or history of deep venous thrombosis, pulmonary embolism,
systemic lupus erythematous, family history of protein S or C deficiencies,
prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high
homocysteine levels.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

3 year overall survival

Safety Issue:

Yes

Principal Investigator

Luhua Wang, Doctor

Investigator Role:

Study Director

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Sciences

Authority:

United States: Food and Drug Administration

Study ID:

CH-L-025

NCT ID:

NCT01503385

Start Date:

December 2011

Completion Date:

December 2016

Related Keywords:

  • Lung Cancer
  • Celecoxib
  • phase II
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location