Status:
COMPLETED
Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Extensive Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, s...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the percentage of patients with extensive stage small cell lung cancer treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months. SECONDAR...
Eligibility Criteria
Inclusion
- 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+
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00118235
Start Date
December 1 2004
End Date
July 1 2011
Last Update
June 17 2014
Active Locations (2)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903