Phase 2
Completed N=47
A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)
Source: ClinicalTrials.gov NCT00318136 ↗Enrolled (actual)
47
Serious AEs
58.1%
Results posted
Apr 2010
Primary outcomePrimary: Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events — 3.2 Percentage of patients
Summary
This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events |
3.2 | — |
| SECONDARY Selected Adverse Events |
2; 0; 0; 2; 1; 1 | — |
| SECONDARY Adverse Events That Led to Discontinuation of Bevacizumab |
1; 1; 1; 2; 1; 1 | — |
| SECONDARY Progression-free Survival |
6.2 | — |
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form(s)
- At least 18 years of age
- Advanced histologically or cytologically confirmed predominant squamous NSCLC
- Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases
- Prior treatment for CNS disease as deemed appropriate by the treating physician
- ECOG performance status 0, 1, or 2
- Measurable or evaluable disease
- Use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study (for women of childbearing potential and sexually active men)
Exclusion Criteria
- Prior chemotherapy for metastatic disease
- Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if 325 mg/day)
- Known hypersensitivity to any components of bevacizumab
- Serious, non-healing wound, ulcer, or bone fracture
- UPC ratio ≥ 1.0
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during the course of the study
- Pregnancy or lactation
- Inadequate organ function
- Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
Data sourced from ClinicalTrials.gov (NCT00318136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.