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

Completed · Phase 2

Conditions studied: Extensive Stage Small Cell Lung Cancer

In brief

This phase II trial is studying how well giving cisplatin and irinotecan together with bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan together with bevacizumab may kill more tumor cells.

Key facts

Study ID

NCT00118235

Run by

National Cancer Institute (NCI)

People needed

72

Starts

2004-12-01

Expected to finish

2011-07-01

Last updated by the study team

2014-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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