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Phase 1b Trial Evaluating the Safety of Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Subjects With Previously Untreated Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

Phase 1b Trial Evaluating the Safety of Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Subjects With Previously Untreated Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 1b, multicenter, open-label, dose-escalation study to evaluate the safety and
tolerability of volociximab in combination with C/P + B in subjects with previously
untreated Stage IIIB/IV non-squamous NSCLC.

Subjects will be treated with the C/P + B + volociximab (V)combination for a total of 6
cycles (3 weeks/cycle). Subjects with stable disease (SD)or better per Response Evaluation
Criteria in Solid Tumors (RECIST)after the 6th cycle of combination treatment (C/P + B + V)
will be considered for further treatment in a maintenance phase with B + V at the same dose
until subject withdrawal from treatment.

Volociximab will be administered at doses ranging from 10 to 30 mg/kg every 3 weeks.
Paclitaxel, carboplatin, and bevacizumab will be administered at their registered doses for
this combination.

Follow up for each subject will extend over a 90-day period following the last dose of
volociximab. End of study is defined as 90 days after the last dose of volociximab for the
last subject treated in the study.

Inclusion Criteria

Inclusion Criteria

- Males and females of at least 18 years of age.

- Stage IIIB with pleural effusion or Stage IV non-squamous NSCLC.

- Measurable and/or evaluable disease according to RECIST.

- No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease.
Adjuvant therapy for early stage disease must have been completed > or = 6 months
prior to Cycle 1, Day 1 of this study.

- Eastern Cooperative Oncology Group (ECOG) performance status < or =1.

- A negative pregnancy test (serum or urine) in women of childbearing potential at
screening. Male subjects and female subjects of childbearing potential must be
willing to practice effective contraception during the study and be willing and able
to continue contraception for 6 months after the last dose of study drug.

- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) (in
accordance with national and local subject privacy regulations).

Exclusion Criteria

- Histological evidence of predominantly squamous cell carcinoma.

- Known central nervous system (CNS) metastases.

- Known allergy or sensitivity to murine proteins, chimeric antibodies or other
components of the product, Cremophor EL (polyoxyethylated castor oil), cisplatin, or
other platinum-containing compounds.

- Absolute neutrophil count (ANC) <1500/mm3, hemoglobin level <10 g/dL, or a platelet
count <100,000/mm3.

- Aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase
values of .2.5 of the upper limits of normal values (ULN) (>5 ULN for subjects with
liver metastases) or alkaline phosphatase values >2.5 ULN (unless documented bone
metastases are responsible for the increase of alkaline phosphatase); total bilirubin
>1.5 mg/dL, or serum creatinine >1.8 mg/dL.

- Radiation therapy within 1 month before Cycle 1, Day 1.

- Documented symptomatic central nervous system (CNS) tumor or CNS metastases.

- History of thromboembolic events, including cardiovascular or cerebrovascular events
(ie, acute myocardial infarction [AMI], stroke) within 1 year prior to Cycle 1, Day

- History of known bleeding disorders and coagulation defects.

- History of significant hemoptysis (ie, > or = 1/2 teaspoon red blood per event) or
gastrointestinal bleeding within 1 year prior to Cycle 1, Day 1.

- Major surgery (eg, exploratory laparotomy) within 4 weeks prior to Cycle 1, Day 1 of
the study.

- Clinically significant or unstable medical conditions including, but not limited to,
uncontrolled diabetes mellitus requiring insulin, uncontrolled hypertension, or
uncontrolled or symptomatic orthostatic hypotension.

- Oxygen-dependent chronic obstructive pulmonary disease.

- Known active infections requiring intravenous (IV) antibiotics, antivirals, or
antifungals, including but not limited to chronic human immunodeficiency virus,
hepatitis B, or hepatitis C infection.

- Prior bone marrow or stem cell transplant.

- Regular use of aspirin, nonsteroidal anti-inflammatory agents, or other agents known
to inhibit platelet function.

- High-dose warfarin or heparin use. [Note: Low-dose warfarin (1 mg/day) or low-dose
heparin for IV-catheter patency, and low-molecular weight heparin for prophylaxis are

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab.

Outcome Time Frame:

Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort

Safety Issue:


Principal Investigator

Mihail Obrocea, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

October 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • cancer
  • carcinoma
  • monoclonal antibody therapy
  • anti-angiogenesis
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Site Reference ID/Investigator# 70354 Bethesda, Maryland  20817-7847
Site Reference ID/Investigator# 70333 Hershey, Pennsylvania  17033-0850
Site Reference ID/Investigator# 70355 Greenville, South Carolina  29605
Site Reference ID/Investigator# 70353 Yakima, Washington  98902