A Phase 1-2 XIAP Antisense AEG35156 With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

* Patients with histologically or cytologically confirmed stage IIIB (malignant pleural effusion) or stage IV non small cell lung cancer who are candidates for carboplatin and paclitaxel chemotherapy for metastatic disease
* ECOG performance \< 2
* One or more tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
* Life expectancy of at least 3 months
* Age \> 18 years
* Signed, written IRB-approved informed consent
* A negative serum pregnancy test (if applicable)
* Acceptable liver function:
* Bilirubin within normal limit
* AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 2.0 times the institution's upper limit of normal
* Acceptable renal function:
* Serum creatinine within normal limits, OR calculated creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Acceptable hematologic status:
* Granulocyte \> 1500 cells/uL
* Platelet count \> 100,000 plt/uL
* Hemoglobin \> 9.0 g/dL
* Acceptable coagulation status:
* PT within normal limits
* PTT within normal limits
* For women of child-bearing potential, the use of effective contraceptive methods during the study
* Prior radiotherapy is allowed provided disease progression outside the radiation field has been documented, treatment completed at least 2 weeks prior to registration and less than 25% of the bone marrow exposed

Exclusion Criteria:

* Prior chemotherapy for metastatic disease.
* Patients with prior history of peripheral neuropathy
* Patients with hypersensitivity to platinum containing compounds, mannitol or drugs formulated in Chremophor EL.
* Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions.
* Known bleeding diathesis
* Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Known infection with HIV, hepatitis B, or hepatitis C
* Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
* Patients who have received any other investigational agent within the last 30 days. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
* Unwillingness or inability to comply with procedures required in this protocol