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Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
celecoxib
docetaxel
adjuvant therapy
radiation therapy
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer meeting ≥ 1 of the following criteria: Stage IIIB disease Stage II or IIIA disease, meeting the following criteria: Considered nonresectable Pleural effusion present Measurable disease Must have received a prior regimen of radiotherapy and chemotherapy comprising docetaxel and carboplatin Tumor volume must be able to be encompassed in the radiation field PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 12 weeks Cardiac function compatible with radiotherapy Neutrophil count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.25 times ULN AST and ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Not pregnant or nursing No other malignancy in the past 10 years except basal cell skin cancer or carcinoma in situ of the cervix No active infection No inflammatory bowel disease No severe congestive heart failure No severe hepatic disease defined as albumin < 25 g/L or Child-Pugh score ≥ 10 No severe renal disease defined as creatinine clearance < 30 mL/min No known hypersensitivity to sulfonamides, the study or it's excipients, or polysorbate 80 No known hypersensitivity of NSAIDs, salicylic acid, or cyclo-oxygenase-2 inhibitors No familial, social, geographical, or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 30 days since participation in another clinical study More than 1 month since prior therapy for gastrointestinal ulcers No concurrent fluconazole, ketoconazole, lithium, or dextromethorphan No other concurrent anticancer treatment including chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic response modifier therapy No concurrent aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) Low-dose aspirin or NSAIDs for a duration of ≤ 1 week during the past 3 months allowed

Sites / Locations

  • Hopital Avicenne
  • Centre Medical de Forcilles Hopital Prive
  • Clinique du Petit Colmouilins
  • Clinique Victor Hugo
  • Polyclinique des Quatre Pavillons
  • Centre de Radiotherapie et Oncologie Saint-Faron
  • American Hospital of Paris
  • Clinique De Valdegour
  • Hopital Saint-Louis
  • Hopital Tenon
  • Clinique les Bleuets
  • Polyclinique De Courlancy
  • Clinique Armoricaine De Radiologie
  • Centre Hospitalier Sud-Reiunion
  • Clinique Sainte Clotilde

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

2-year survival rate
Quality of life
Weight changes
Objective response
Tolerability

Full Information

First Posted
January 10, 2006
Last Updated
February 6, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00274898
Brief Title
Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Official Title
Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Compare the time to progression in patients with stage II-IIIB non-small cell lung cancer treated with celecoxib vs observation after treatment with chemoradiotherapy. Secondary Compare the 2-year survival rate of patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare weight changes and objective response in patients treated with these regimens. Compare tolerability of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and total dose of radiotherapy (65 Gy vs 60 Gy). All patients undergo radiotherapy 5 days a week for 7.5 weeks. Patients also receive docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Three weeks after the completion of radiotherapy, patients receive docetaxel alone IV over 30 minutes on days 1 and 22. Three weeks later, patients are randomized to 1 of 2 treatment arms. Arm I: Patients are observed every 3 months for 1 year and then every 6 months for 1 year. Arm II: Patients receive oral celecoxib twice daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Time to progression
Secondary Outcome Measure Information:
Title
2-year survival rate
Title
Quality of life
Title
Weight changes
Title
Objective response
Title
Tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer meeting ≥ 1 of the following criteria: Stage IIIB disease Stage II or IIIA disease, meeting the following criteria: Considered nonresectable Pleural effusion present Measurable disease Must have received a prior regimen of radiotherapy and chemotherapy comprising docetaxel and carboplatin Tumor volume must be able to be encompassed in the radiation field PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 12 weeks Cardiac function compatible with radiotherapy Neutrophil count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.25 times ULN AST and ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Not pregnant or nursing No other malignancy in the past 10 years except basal cell skin cancer or carcinoma in situ of the cervix No active infection No inflammatory bowel disease No severe congestive heart failure No severe hepatic disease defined as albumin < 25 g/L or Child-Pugh score ≥ 10 No severe renal disease defined as creatinine clearance < 30 mL/min No known hypersensitivity to sulfonamides, the study or it's excipients, or polysorbate 80 No known hypersensitivity of NSAIDs, salicylic acid, or cyclo-oxygenase-2 inhibitors No familial, social, geographical, or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 30 days since participation in another clinical study More than 1 month since prior therapy for gastrointestinal ulcers No concurrent fluconazole, ketoconazole, lithium, or dextromethorphan No other concurrent anticancer treatment including chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic response modifier therapy No concurrent aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) Low-dose aspirin or NSAIDs for a duration of ≤ 1 week during the past 3 months allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean F. Morere, MD
Organizational Affiliation
Hopital Avicenne
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Centre Medical de Forcilles Hopital Prive
City
Ferroles Attilly
ZIP/Postal Code
77150
Country
France
Facility Name
Clinique du Petit Colmouilins
City
Harfleur
ZIP/Postal Code
76700
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
F-72000
Country
France
Facility Name
Polyclinique des Quatre Pavillons
City
Lormont
ZIP/Postal Code
33310
Country
France
Facility Name
Centre de Radiotherapie et Oncologie Saint-Faron
City
Mareuil Les Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
Clinique De Valdegour
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique les Bleuets
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Centre Hospitalier Sud-Reiunion
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Facility Name
Clinique Sainte Clotilde
City
Sainte Clotilde
ZIP/Postal Code
97192
Country
France

12. IPD Sharing Statement

Learn more about this trial

Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

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