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

NCT00702572 | Terminated Phase 1 DMC

• 1 other identifier: PSHCI 08-004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Phase I; Advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

  An average of 2 years

Secondary Outcomes (1)

• 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.

  Average of 2 years

Study Arms (2)

1

EXPERIMENTAL

Phase I dose escalating scheme

Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

2

EXPERIMENTAL

Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.

Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

Interventions

Vorinostat, Bevacizumab, Carboplatin, Paclitaxel DRUG

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.

Also known as: SAHA

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of brain metastasis
• Evidence of thromboembolic phenomenon and treatment with anticoagulants
• Pregnancy
• Uncontrolled inter-current illness
• Prior therapy with Paclitaxel

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vorinostat; Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Chandra P Belani, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (1)