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Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Low Enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702572
First Posted: June 20, 2008
Last Update Posted: September 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chandra P. Belani, Milton S. Hershey Medical Center
June 19, 2008
June 20, 2008
September 22, 2016
April 2008
May 2016   (Final data collection date for primary 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. [ Time Frame: An average of 2 years ]
Participants will be followed for survival, an expected average of two years.
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. [ Time Frame: End of study ]
Complete list of historical versions of study NCT00702572 on ClinicalTrials.gov Archive Site
Evaluate safety profile of 4-drug regimen. Obtain preliminary evidence regarding anti-cancer activity of the regimen. Understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue. [ Time Frame: Average of 2 years ]
Participants will be followed for survival, an expected average of 2 years.
Evaluate safety profile of 4-drug regimen. Obtain preliminary evidence regarding anti-cancer activity of the regimen. Understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue. [ Time Frame: End of study ]
Not Provided
Not Provided
 
Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer
Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
The primary objective of the study is to establish the phase II recommended dose of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
    This dose escalating phase will enroll sequential cohorts of 3-6 patients to be entered at the following dose levels: Level -1: Days 1-14, Vorinostat 100 mg po QD; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 175 mg/m2. Level 1: Days 1-14, Vorinostat 200 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 2: Days 1-14, Vorinostat 300 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 3: Days 1-14, Vorinostat 400 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Treatment cycles will be repeated every 3 weeks. The highest dose level which <2 out of 5 patients experience dose limiting toxicity will be defined as the recommended phase II dose.
    Other Name: SAHA
  • Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
    Once the recommended phase II dose has been established from Phase I, 12 additional patients will be treated to evaluate the toxicities and safety profile of the 4-drug regimen.
    Other Name: SAHA
  • Experimental: 1
    Phase I dose escalating scheme
    Intervention: Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
  • Experimental: 2
    Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
    Intervention: Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
September 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00702572
PSHCI 08-004
Yes
Not Provided
Not Provided
Chandra P. Belani, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Chandra P Belani, MD Penn State College of Medicine
Milton S. Hershey Medical Center
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP