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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Safety Issue:

No

Principal Investigator

Jean F. Morere, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Avicenne

Authority:

United States: Federal Government

Study ID:

CDR0000454352

NCT ID:

NCT00274898

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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