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Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen
for the treatment of advanced non-squamous NSCLC, new studies in this patient population
will have to include this as a reference arm. Addition of a fourth anti-cancer agent has
now become the new strategy to improve the outcome for advanced non-squamous NSCLC. Since
the regimen of Vorinostat, Carboplatin and Paclitaxel is already in advanced stage of
development it is important to study the safety and tolerability of Vorinostat in
combination with the three-drug regimen of Bevacizumab, Carboplatin and Paclitaxel.
Therefore, we will evaluate Vorinostat when administered in combination with the regimen of
Carboplatin, Paclitaxel and Bevacizumab for patients with previously untreated advanced
non-small cell lung cancer.


Inclusion Criteria:



- Advanced non-squamous NSCLC

- No prior chemotherapy for advanced disease

- ECOG performance status 0 or 1

- Measurable disease

- Life expectancy > 3 months

- Normal bone marrow, renal and hepatic function

- Ability to take oral medications

- Willingness to sign informed consent

Exclusion Criteria:

- History of brain metastasis

- Evidence of thromboembolic phenomenon and treatment with anticoagulants

- Pregnancy

- Uncontrolled inter-current illness

- Prior therapy with Paclitaxel

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the phase II recommended dose (P2RD) of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer.

Outcome Description:

Participants will be followed for survival, an expected average of two years.

Outcome Time Frame:

An average of 2 years

Safety Issue:

No

Principal Investigator

Chandra P Belani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

PSHCI 08-004

NCT ID:

NCT00702572

Start Date:

April 2008

Completion Date:

May 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Phase I
  • Advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Penn State College of Medicine, Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033