Clinical trial NCT00274898: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to progression
Secondary outcomes:
measure: 2-year survival rate
measure: Quality of life
measure: Weight changes
measure: Objective response
measure: Tolerability
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital Avicenne
city: Ferroles Attilly
country: France
facility: Centre Medical de Forcilles Hopital Prive
city: Harfleur
country: France
facility: Clinique du Petit Colmouilins
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lormont
country: France
facility: Polyclinique des Quatre Pavillons
city: Mareuil Les Meaux
country: France
facility: Centre de Radiotherapie et Oncologie Saint-Faron
city: Neuilly Sur Seine
country: France
facility: American Hospital of Paris
city: Nimes
country: France
facility: Clinique De Valdegour
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Tenon
city: Reims
country: France
facility: Clinique les Bleuets
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Saint Brieuc
country: France
facility: Clinique Armoricaine De Radiologie
city: Saint Pierre
country: France
facility: Centre Hospitalier Sud-Reiunion
city: Sainte Clotilde
country: France
facility: Clinique Sainte Clotilde
Study officials:
affiliation: Hopital Avicenne
name: Jean F. Morere, MD
role: STUDY_CHAIR
References: