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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
  Purpose
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 Intervention Phase
Non-small Cell Lung Cancer Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Chandra P. Belani, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 25
Study Start Date: April 2008
Study Completion Date: September 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Phase I dose escalating scheme
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
Experimental: 2
Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702572


Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Chandra P Belani, MD Penn State College of Medicine
  More Information

Responsible Party: Chandra P. Belani, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00702572     History of Changes
Other Study ID Numbers: PSHCI 08-004
First Submitted: June 19, 2008
First Posted: June 20, 2008
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Chandra P. Belani, Milton S. Hershey Medical Center:
Phase I
Advanced non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Vorinostat
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Histone Deacetylase Inhibitors
Enzyme Inhibitors