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

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ClinicalTrials.gov Identifier: NCT01503385
Recruitment Status : Unknown
Verified January 2012 by Luhua Wang, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 4, 2012
Last Update Posted : January 4, 2012
Sponsor:
Information provided by (Responsible Party):
Luhua Wang, Chinese Academy of Medical Sciences

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : December 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: Celebrex




Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 year overall survival ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 3 year progression-free survival ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503385


Contacts
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Contact: Jun Liang, Doctor 8610-87788503 lj139117@yahoo.com.cn

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Liang Jun, Doctor    +861087788503    lj139117@yahoo.com.cn   
Contact: Wang luhua, Doctor    +861087788799    wlhwq@yahoo.com   
Sub-Investigator: Chen Bo, Doctor         
Jun Liang Recruiting
Beijing, Beijing, China, 100021
Contact: Jun Liang, Doctor    8610-87788503    lj139117@yahoo.com.cn   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Director: Luhua Wang, Doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Luhua Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01503385     History of Changes
Other Study ID Numbers: CH-L-025
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: January 2012
Keywords provided by Luhua Wang, Chinese Academy of Medical Sciences:
Celecoxib
phase II
Additional relevant MeSH terms:
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Celecoxib
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors