Randomized Study of Docetaxel Versus Docetaxel Plus Genasense™ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of non-small lung cancer (NSCLC)

- Stage IIIB (malignant pleural/pericardial effusion) or IV

- Relapsed or refractory disease

- Measurable disease that has not been irradiated

- Previously treated with 1, and only 1, cytotoxic chemotherapy regimen in the
neoadjuvant, adjuvant, or metastatic setting

- No untreated or symptomatic brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3 (without growth factor support)

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

- No bleeding or coagulation disorder

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT and AST no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- Albumin at least 3.0 g/dL

- PT no greater than 1.5 times ULN OR INR no greater than 1.3

- PTT no greater than 1.5 times ULN

- No chronic hepatitis

- No chronic cirrhosis

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No New York Heart Association class III or IV heart disease

- No uncontrolled congestive heart failure

Pulmonary:

- No severe pulmonary disease

- No requirement for oxygen due to pneumonectomy

- No severe pleural effusion secondary to NSCLC

Immunologic:

- HIV negative

- No active infection

- No active autoimmune disease

Other:

- No other concurrent active cancer

- No uncontrolled diabetes mellitus

- No uncontrolled seizure disorder

- No peripheral neuropathy grade 2 or greater

- No active peptic ulcer disease

- No other significant medical disease

- No intellectual, emotional, or physical disability that would preclude study
participation

- No neurologic disorders, overt psychosis, mental disability, or evidence of a limited
capacity to give informed consent or to comply with study treatment

- No known hypersensitivity to phosphorothioate-containing oligonucleotides

- No history of hypersensitivity to drugs containing the excipient Tween 80
(polysorbate 80)

- Satisfactory venous access for multi-day continuous infusion

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior cytokines or vaccine therapy for NSCLC

- At least 3 weeks since prior immunotherapy or biologic therapy for NSCLC

- No concurrent anticancer biologic therapy

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy for NSCLC

- No prior docetaxel

- No other concurrent anticancer chemotherapy

Endocrine therapy:

- No concurrent corticosteroids* except for the following conditions:

- CNS disease

- Underlying lung disease NOTE: *Dose must be stable or decreasing for at least 4
weeks before study participation

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for NSCLC

- No prior radiotherapy to 25% or more of bone marrow (e.g., whole pelvis)

- No concurrent anticancer radiotherapy

Surgery:

- At least 3 weeks since prior surgery for NSCLC

- No prior organ allograft

Other:

- Recovered from prior therapy

- Prior first-line epidermal growth factor receptors (EGFR) administered with cytotoxic
therapy are allowed

- At least 3 weeks since prior investigational drugs

- At least 3 weeks since other prior therapy NSCLC

- No prior anticancer therapy subsequent to the first (and only) prior cytotoxic
chemotherapy regimen

- No prior second-line EGFR therapy

- No prior oblimersen (G3139)

- No other concurrent investigational or anticancer therapies

- No concurrent anticoagulation therapy except for warfarin (1 mg/day) for central line
prophylaxis