Status:
TERMINATED
Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Lung
Bronchoalveolar Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung ca...
Detailed Description
PRIMARY OBJECTIVES: I. Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest radiotherapy in patients with locally advanced non-small cell lung cancer. II. Characte...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:
- The following subtypes are eligible:
- Adenocarcinoma (including bronchoalveolar)
- Large cell carcinoma (including giant and clear cell carcinomas)
- Poorly differentiated carcinoma
- No squamous cell histology
- Unresectable stage II-III disease
- Tumor must not invade the trachea or major arterial or venous structures
- Measurable or evaluable disease
- Measurable disease defined as ? 1 lesion that can be accurately measured in ? 1 dimension as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan
- No evidence of CNS disease, including primary brain tumor or brain metastases
- ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
- Life expectancy \> 6 months
- Granulocyte count ? 1,500/mm³
- Platelet count ? 100,000/mm³
- Bilirubin \< 1.25 times upper limit of normal (ULN)
- AST \< 2.5 times ULN
- Creatinine normalOR creatinine clearance ? 60 mL/min
- FEV\_1 ? 1.0 liters
- 24-hour urine protein \< 1,000 mg (for patients with urine protein:creatinine ratio \[by urine analysis\] \> 1.0)
- No hemoptysis within the past 12 months (defined as bright red blood in sputum of \> 1 teaspoon)
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No history of allergic reactions attributed to carboplatin or taxane
- No serious or nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No significant traumatic injury within the past 14 days
- No clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident within the past 6 months
- Uncontrolled hypertension
- Myocardial infarction or unstable angina within the past 6 months
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Unstable angina pectoris
- Clinically significant peripheral vascular disease
- No known bleeding diathesis or coagulopathy
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- No uncontrolled intercurrent illness including, but not limited to, the following:
- Ongoing or active infection
- Psychiatric illness or social situations that would limit study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
- No HIV positivity
- No prior chemotherapy
- No prior epidermal growth factor receptor-targeted therapy
- No prior vascular endothelial growth factor-targeted therapy
- No prior chest radiotherapy
- No major surgery or open biopsy within the past 14 days
- No concurrent treatment with full-dose anticoagulation
- Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:
- Daily dose of warfarin \< 1 mg
- INR \< 1.5
- No other concurrent investigational agents
- No concurrent major surgical procedures
- No other concurrent anticancer agents or therapies
- No concurrent chronic treatment with aspirin (\> 325 mg daily) or nonsteroidal anti-inflammatory agents
- No dexamethasone as an antiemetic during chemoradiotherapy
- No colony-stimulating factors during chemoradiotherapy
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00369551
Start Date
June 1 2006
Last Update
March 6 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637