Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01503385

Collaborator

(none)

100

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP) regimen is one of the most commonly used regimens. However, the prognosis of these patients is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote chemosensitivity and radiosensitivity of tumor cells in preclinical trials.

This is a single-institution, open-label, randomized phase II trial of celecoxib administered concurrently with cisplatin, etoposide, and radiation therapy in patients with locally advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Celecoxib	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celecoxib Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib. Intervention: Drug: Celecoxib	Drug: Celecoxib 400 mg by mouth twice daily for for 5-7 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 6 weeks). Other Names: Celebrex

Arm

Intervention/Treatment

Experimental: Celecoxib

Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib. Intervention: Drug: Celecoxib

Drug: Celecoxib

400 mg by mouth twice daily for for 5-7 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 6 weeks).

Other Names:

Celebrex

Outcome Measures

Primary Outcome Measures

overall survival [3 year overall survival]

Secondary Outcome Measures

progression-free survival [3 year progression-free survival]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021
2	Jun Liang	Beijing	Beijing	China	100021

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Study Director: Luhua Wang, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luhua Wang, Luhua Wang, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01503385

Other Study ID Numbers:

CH-L-025

First Posted:

Jan 4, 2012

Last Update Posted:

Jan 4, 2012

Last Verified:

Jan 1, 2012

Keywords provided by Luhua Wang, Luhua Wang, Chinese Academy of Medical Sciences

Celecoxib

phase II

Additional relevant MeSH terms:

Lung Neoplasms

Celecoxib

Study Results

No Results Posted as of Jan 4, 2012