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Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies



- To determine the response rate, in terms of overall response rate (complete response
and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and
carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who
are ineligible for treatment with bevacizumab.


- To evaluate safety of this regimen in these patients.

- To describe the overall survival of these patients.

- To describe progression-free survival of these patients.

Tertiary Objectives

- To explore, in a pilot fashion, the activity of this regimen using predictive
biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples
and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA
expression profiles.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.

Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for
correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND
SPARC by immunohistochemistry, and serum miRNA expression profiling.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


- Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC)
meeting 1 of the following criteria:

- Stage IIIB disease with malignant pleural effusion

- Stage IV disease

- Recurrent disease

- Squamous cell histology allowed

- Not eligible for curative treatment or treatment with bevacizumab

- Measurable disease according to RECIST

- Tumor (paraffin blocks or slides) must be available for correlative biomarker studies

- No uncontrolled brain metastases (or leptomeningeal disease)

- Controlled brain metastases allowed

- Able to receive appropriate therapeutic radiotherapy

- Able to taper off all steroids without symptoms suggestive of increased
intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at
least 7 days


- ECOG performance status 0-2

- ANC ≥ 1.5 x 10^9/L

- Platelets ≥ 100 x 10^9/L

- Hemoglobin ≥ 9.0 g/L

- Total bilirubin ≤ 1.5 mg/dL

- AST and ALT < 2.5 times upper limit of normal

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mg/mL

- No known HIV or hepatitis B or C

- Not pregnant

- Negative pregnancy test

- Thrombotic or embolic event within the past 6 months allowed, provided adequately
controlled with therapeutic anticoagulation

- Hemoptysis allowed, provided it is not life threatening or requires palliative
procedures (e.g., endobronchial therapy or radiotherapy)

- No cardiac disease, including any of the following:

- NYHA class III-IV congestive heart failure

- Unstable angina (angina symptoms at rest)

- New onset angina (began within the past 3 months)

- Myocardial infarction within the past 6 months

- No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or
diastolic BP > 90 mm Hg despite optimal medical management

- No peripheral neuropathy ≥ grade 2

- No active clinically serious infection > CTCAE grade 2

- No serious non-healing wound, ulcer, or bone fracture

- No significant traumatic injury within the past 4 weeks

- No evidence or history of bleeding diathesis or coagulopathy

- No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma
in situ of the cervix, or other cancer for which the patient has been disease-free
for 2 years

- Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of
NSCLC allowed, however metastatic prostate cancer currently receiving hormonal
therapy or chemotherapy is not allowed

- No significant psychiatric illness, in the opinion of the principal investigator,
that would prevent adequate informed consent or render therapy unsafe


- See Disease Characteristics

- Concurrent therapeutic anticoagulation, > 325 mg acetylsalicylic acid, or chronic
non-steroid anti-inflammatory drug use allowed

- At least 14 days since prior and no concurrent radiotherapy

- More than 4 weeks since prior major surgery or open biopsy

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Response rate as defined by RECIST

Safety Issue:


Principal Investigator

Gregory A. Otterson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center



Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240