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Phase II Study to Assess the Safety and Efficacy of Carboplatin, Paclitaxel and Bevacizumab ± Combretastatin A4 Phosphate (CA4P) Followed by Bevacizumab ± CA4P in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study to Assess the Safety and Efficacy of Carboplatin, Paclitaxel and Bevacizumab ± Combretastatin A4 Phosphate (CA4P) Followed by Bevacizumab ± CA4P in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Lung cancer has become the leading cause of cancer death in both men and women in the US and
Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC)
accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment
is available for advanced stages of the disease (stages III and IV), which comprise the
majority of cases. Treatment with the combination of carboplatin and paclitaxel has been
shown to be effective and well tolerated in advanced stage NSCLC. Targeted therapies, such
as bevacizumab, often act synergistically with chemotherapy. Bevacizumab inhibits VEGF,
necessary for endothelial cell proliferation and new blood vessel formation. CA4P targets
existing abnormal vasculature of tumors, impeding tumor blood flow and leading to extensive
tumor cell death as a consequence of oxygen and nutrient deprivation.

This study will compare the effect of CA4P when combined with chemotherapy and bevacizumab
on progression free survival (PFS) to PFS after chemotherapy and bevacizumab alone.

Inclusion Criteria:

- Pathologically confirmed Stage IIIB NSCLC with malignant pleural effusion, or Stage
IV disease

- Measurable disease on CT scan (by the RECIST criteria)

- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 (which means
able to independently care for self and to perform light work) .

- Adequate blood counts

- Adequate liver and kidney function

- Subjects or their legal representatives must be able to read, understand and provide
written informed consent to participate in the trial.

Exclusion Criteria:

- Predominant Squamous Cell NSCLC histology.

- History of treatment for NSCLC with chemotherapy, biological therapy, immunotherapy
(surgery or radiation therapy are accepted)

- Brain (CNS) metastasis by head CT scan or MRI

- Subjects with history of prior malignancy except for curatively treated basal cell
carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate
cancer with a current prostate specific antigen (PSA) of < 4.0 mg/dL. Subjects with
other curatively treated malignancies who have no evidence of metastatic disease and
>2 year disease free interval may be entered after discussion with the Medical

- History of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood
during the last 3 months

- Certain cardiac disorders such as recent myocardial infarction (MI), severe
congestive heart failure, certain types of abnormal cardiac rhythm

- Uncontrolled high blood pressure despite medications

- Uncontrolled, clinically significant active infection.

- Known HIV

- Known hypersensitivity to any of the components of CA4P, paclitaxel, carboplatin,
bevacizumab, or radiologic contrast dyes.

Details of the above and additional inclusion and exclusion criteria can be discussed with
an investigator.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of the combination therapy assessed by analysis of adverse events, physical examination, blood tests, ECGs

Outcome Time Frame:

Six 21-day cycles

Safety Issue:


Principal Investigator

Jai Balkissoon, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

October 2011

Related Keywords:

  • Tumors
  • non-small cell lung cancer
  • non-small cell lung carcinoma
  • neoplasms, lung
  • lung cancer
  • tumors
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Kentuckiana Cancer InstituteLouisville, Kentucky  40202
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Gabrail Cancer CenterCanton, Ohio  44718
Bay Area Cancer Research Group, LLCConcord, California  94520
San Juan Oncology AssociatesFarmington, New Mexico  87401
Northwest Medical SpecialtiesTacoma, Washington  98405
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Southbay Oncology HematologyCampbell, California  95008
Pacific Coast Hematology and Oncology Medical GroupFountain Valley, California  92708
UCLA Division of Hematology and OncologyLos Angeles, California  90095
The Mark H. Zangmeister CenterColumbus, Ohio  43219
Signal Point Clinical ResearchMiddletown, Ohio  45042
Blueridge Cancer CareSalem, Virginia  24153
Mary Babb Randolph Cancer Center-Clinical Trials UnitMorgantown, West Virginia  26506