Clinical trial NCT01323062: Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
Official title: A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: chemotherapy naive
stage IV non squamous non small cell lung cancer
Phase 1b
Bavituximab
Chimeric 3G4
U of North Carolina at Chapel Hill
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Peregrine Pharmaceuticals
First posted: 2011-03-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).

Detailed description: Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18
* Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy
* Evaluable disease by clinical or radiographic parameters
* No history or concomitant malignancy
* Adequate organ and marrow function
* Female subjects with negative urine or serum pregnancy
* ECOG must be 0 or 1

Exclusion Criteria:

* Squamous cell, small cell, or mixed histology
* Known history of bleeding diathesis or coagulopathy
* Cavitary tumors or tumors invading or abutting large blood vessels
* Any history of thromboembolic events
* Ongoing therapy with oral or parenteral anticoagulants
* Major surgery within 4 weeks of Day 1 of treatment
* Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease)
* any history of significant vascular disease
* Congestive heart failure
* History of any condition requiring anti-platelet therapy
* Serious non healing wound
* Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis
* Unable or unwilling to discontinue use of prohibited medications
* D-dimers \>2 x ULN as measured on 2 separate occasions at least 1 day apart

Primary outcomes:
measure: Measure number of severe side effects seen during first cycle of therapy
timeFrame: Three weeks
Secondary outcomes:
measure: Progression free survival
timeFrame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: U of North Carolina at Chapel Hill
name: Juneko Grilley Olson, MD
role: PRINCIPAL_INVESTIGATOR
References: