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

This study is currently recruiting participants.
Verified on July 2011 by Penn State University

First Received on June 19, 2008.  
Last Updated on July 19, 2011  
History of Changes
This Clinical Trial Sponsored By: Penn State University
Information provided by: Penn State University
ClinicalTrials.gov Identifier: NCT00702572
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
Non-small Cell Lung Cancer Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel Phase I

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lung Cancer
Drug Information available for:
Paclitaxel
Carboplatin
Suberoylanilide hydroxamic acid
Bevacizumab

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]
    Participants will be followed for survival, an expected average of two years.

Secondary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: Yes ]
    Participants will be followed for survival, an expected average of 2 years.

Estimated Enrollment: 25
Study Start Date: April 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

1: Experimental

Phase I dose escalating scheme
Study Intervention: Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
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
2: Experimental

Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
Study Intervention: Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702572

Contacts
Contact: Chandra P. Belani, MD 717-531-1078 cbelani@hmc.psu.edu

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