A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318136
• Other study ID #: AVF3744g
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2006
• Last updated: May 5, 2010
• Start date: September 2005
• Est. completion date: July 2009

Study information

• Verified date: May 2010
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 < 6 months has elapsed from completion of treatment to Day 1, Cycle 1

• Extrathoracic metastases as the only sites of disease

• Active malignancy other than lung cancer

• Current, recent, or planned participation in another experimental drug study

• Untreated brain metastases

• Presence of intrathoracic lesion(s) with any cavitation

• Gross hemoptysis within 3 months prior to Day 1

• In the opinion of the investigator or local radiologist, evidence of tumor that is extending into the lumen of a major blood vessel

• Inadequately controlled hypertension

• Unstable angina or NYHA Grade II or greater CHF

• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1

• Myocardial infarction within 6 months prior to Day 1, Cycle 1

• Stroke within 6 months prior to Day 1, Cycle 1

• Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1

• History of significant vascular disease

• Evidence of bleeding diathesis or coagulopathy

• Current, ongoing treatment with full-dose warfarin or its equivalent

• Current or recent use of aspirin (>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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Bevacizumab
15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
• Carboplatin
Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
• Paclitaxel
Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Grade =3 Pulmonary Hemorrhage Adverse Events	To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade =3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."	First bevacizumab administration until 60 days after discontinuation of bevacizumab or death	Yes
Secondary	Selected Adverse Events	Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade = 2 arterial thromboembolic events, Grade = 2 left ventricular systolic dysfunction, Grade = 3 proteinuria, and Grade = 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions.; Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting.	First bevacizumab administration until 60 days after discontinuation of bevacizumab or death	Yes
Secondary	Adverse Events That Led to Discontinuation of Bevacizumab	Any treatment-emergent adverse event leading to study treatment discontinuation	First bevacizumab administration until 60 days after discontinuation of bevacizumab or death	No
Secondary	Progression-free Survival	Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab.; Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.	Length of study	No