Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer

Inclusion Criteria:

• All patients must have histologically or cytologically documented small cell carcinoma of the bronchus
• The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy
• Measurable or Non-measurable Disease
• No prior chemotherapy or investigational therapy for SCLC
• Radiation therapy must have been completed at least three weeks before initiation of protocol therapy
• No major surgical procedure within 28 days prior to starting treatment and fully recovered
• No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment
• ECOG performance status: 0-2
• No "currently active" second malignancy other than non-melanoma skin cancers
• No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases
• No recent history of CVA (within 6 months)
• No serious or non-healing wound ulcer or bone fracture
• Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible
• No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher)
• Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy
• No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with the protocol treatment; (patients with immune deficiency are at an increased risk of lethal infections when treated with marrow-suppressive therapy)
• No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal antiinflammatory agents known to inhibit platelet function; no treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol (Pletal), or other antiplatelet agents
• No clinically significant peripheral neuropathy (grade >= 2)
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No treatment with therapeutic anticoagulation; prophylactic anticoagulation for central venous access devices is allowed provided requirements of INR < 1.5 and PTT < 1.2 x ULN are met; caution should be taken in treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis as there may be an increased bleeding risk with bevacizumab
• No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed
• No clinically significant peripheral arterial disease
• Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown
• Granulocytes >= 1,500/μl
• Platelets >= 100,000/μl
• Serum Creatinine =< ULN
• Total Bilirubin < 2.0 mg/dl
• SGOT < 2 x ULN
• INR < 1.5
• PTT < 1.2 x ULN
• Urine protein (dipstick) < 1+