Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsor:	Fox Chase Cancer Center
Collaborator:	National Comprehensive Cancer Network
Information provided by:	Fox Chase Cancer Center
ClinicalTrials.gov Identifier:	NCT01059552

Purpose

The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.

Condition	Intervention	Phase
Locally Advanced Non-small Cell Lung Cancer	Drug: vorinostat	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Vorinostat

U.S. FDA Resources

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:

To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC. [ Time Frame: toxicity assessments will occur weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate progression free survival. [ Time Frame: CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression ] [ Designated as safety issue: No ]
To evaluate response rates with this combination [ Time Frame: CT/PET will be done following 12 weeks of therapy. ] [ Designated as safety issue: No ]
To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate. [ Time Frame: Archival tissue will be tested and correlated to response rates. ] [ Designated as safety issue: No ]

Estimated Enrollment:	22
Study Start Date:	December 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: vorinostat Dose escalation of vorinostat, cisplatin, pemetrexed and radiation	Drug: vorinostat vorinostat once daily for 12 weeks of therapy Other Name: Zolinza

Detailed Description:

This phase I trial will escalate doses of the histone deacetylase inhibitor (HDAC) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70Gy in NSCLC patients with unresectable IIIA and dry IIIB disease. The endpoint will be to determine MTD of the combination.

Eligibility

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

Criteria

Inclusion Criteria:

biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease.
FEV1 >/= 1 liter
ECOG PS 0 or 1
Able to swallow and absorb enterally
Measurable disease per RECIST 1.1
Adequate organ and marrow function including calculated creatinine clearance >/= 60 mL/min hepatic enzymes and alk phos </= 2.5 X ULN.

Exclusion Criteria:

Chemotherapy or radiotherapy </= 4 weeks prior to registration (6 weeks for nitrosureas)
Active bleeding
Known brain mets
Prior thoracic radiotherapy that would lead to overlap with current radiation field.
More than 10% weight loss in 6 months.
Pancoast tumors, supraclavicular or contralateral hilar lymph node involvement
Known HIV positive
Prior treatment with an HDAC inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059552

Contacts

Contact: Ranee Mehra, MD	215-728-2985	ranee.mehra@fccc.edu
Contact: Holly Tuttle, MSN	215-728-2451	holly.tuttle@fccc.edu

Locations

United States, Florida
Moffitt Cancer Cetner	Recruiting
Tampa, Florida, United States, 33612
Contact: Anglea Tolemeo 813-745-4625 angela.tolomeo@moffitt.org
Contact: Mary Pinder, MD Mary.Pinder@moffitt.org
Principal Investigator: Mary Pinder, MD
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Marianne Bonner, RN, BSN 215-728-2769 marianne.bonner@fccc.edu
Principal Investigator: Ranee Mehra, MD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Shanta Salzer 843-792-1463 salzers@musc.edu
Contact: Keisuke Shirai, MD, MSCR 843-792-8584 shirai@musc.edu
Principal Investigator: Keisuke Shirai, MD

Sponsors and Collaborators

Fox Chase Cancer Center

National Comprehensive Cancer Network

Investigators

Principal Investigator:

Ranee Mehra, MD

Fox Chase Cancer Center

More Information

No publications provided

Responsible Party:	Judi Sylvester, Director, Office of Extramural Research Program
ClinicalTrials.gov Identifier:	NCT01059552 History of Changes
Other Study ID Numbers:	FER-TH-031
Study First Received:	January 28, 2010
Last Updated:	June 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:

lung cancer
locally advanced lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Respiratory Tract Diseases
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012