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

NCT01503385 | Unknown Phase 2 DMC

• 1 other identifier: CH-L-025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

Celecoxib; phase II

Outcome Measures

Primary Outcomes (1)

• overall survival

  3 year overall survival

Secondary Outcomes (1)

• progression-free survival

  3 year progression-free survival

Study Arms (1)

Celecoxib

EXPERIMENTAL

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

Drug: Celecoxib

Interventions

Celecoxib 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).

Also known as: Celebrex

Celecoxib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Jun Liang

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31851351 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luhua Wang, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Jun Liang, Doctor

CONTACT

8610-87788503; lj139117@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Luhua Wang

Study Record Dates

• First Submitted: January 1, 2012
• First Posted: January 4, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: January 4, 2012

Record last verified: 2012-01

Locations

CN (2)