Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

- Stage IV

- Stage IIIB with a malignant pleural effusion

- Locally recurrent and/or persistent disease after locoregional therapy with or
without systemic chemotherapy

- Unidimensionally measurable disease

- If the only site of measurable disease is in a previously irradiated area must
have documented progression of disease in that area

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin normal

- AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase
is normal)

- Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)

Renal

- Creatinine less than 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
treatment

- No other malignancy within the past 5 years except curatively treated squamous cell
or basal cell skin cancer or carcinoma in situ of the cervix

- No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days

- No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal
anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with
polysorbate 80

- No pre-existing grade 2 or greater peripheral neuropathy

- No concurrent medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 1 week since prior biologic therapy

- Phase I patients:

- Any number of prior biologic therapies allowed (e.g., chimeric antibodies or
kinase inhibitors)

- Phase II patients:

- No prior biologic therapy for recurrent/metastatic disease

- No concurrent filgrastim (G-CSF)

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- No prior irinotecan or docetaxel

- Phase I patients:

- Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed
(chemonaïve patients are also eligible)

- Phase II patients:

- At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage
I-IIIA disease

- No prior chemotherapy for recurrent/metastatic disease

Endocrine therapy

- Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

- At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic
disease

Surgery

- Recovered from prior surgery

Other

- More than 60 days since prior treatment for peptic ulcer disease or
gastritis/esophagitis

- No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period
of more than 2 weeks within the past 30 days

- No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole

- No concurrent NSAIDs

- No other concurrent COX-2 inhibitors