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

NCT ID: NCT01503385

Last Updated: 2012-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Celecoxib

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

Intervention: Drug: Celecoxib

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Celebrex

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Luhua Wang

Luhua Wang

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luhua Wang, Doctor

Role: STUDY_DIRECTOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Jun Liang

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Liang, Doctor

Role: CONTACT

lj139117@yahoo.com.cn

8610-87788503

Facility Contacts

Liang Jun, Doctor

Role: primary

lj139117@yahoo.com.cn

+861087788503

Wang luhua, Doctor

Role: backup

wlhwq@yahoo.com

+861087788799

Jun Liang, Doctor

Role: primary

lj139117@yahoo.com.cn

8610-87788503

References

Bi N, Liang J, Zhou Z, Chen D, Fu Z, Yang X, Feng Q, Hui Z, Xiao Z, Lv J, Wang X, Zhang T, Wang X, Deng L, Wang W, Wang J, Liu L, Hu C, Wang L. Effect of Concurrent Chemoradiation With Celecoxib vs Concurrent Chemoradiation Alone on Survival Among Patients With Non-Small Cell Lung Cancer With and Without Cyclooxygenase 2 Genetic Variants: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918070. doi: 10.1001/jamanetworkopen.2019.18070.

Reference Type: DERIVED

PMID: 31851351 (View on PubMed)

Other Identifiers

CH-L-025

Identifier Type: -

Identifier Source: org_study_id