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

NCT01059552 | Completed Phase 1 DMC

• 2 other identifiers: FER-TH-031NCI-2010-01913
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Locally Advanced Non-small Cell Lung Cancer

Keywords

lung cancer; locally advanced lung cancer

Outcome Measures

Primary Outcomes (1)

• To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.

  toxicity assessments will occur weekly

Secondary Outcomes (3)

• To investigate progression free survival.

  CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression

• To evaluate response rates with this combination

  CT/PET will be done following 12 weeks of therapy.

• To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate.

  Archival tissue will be tested and correlated to response rates.

Study Arms (1)

vorinostat

EXPERIMENTAL

Dose escalation of vorinostat, cisplatin, pemetrexed and radiation

Drug: vorinostat

Interventions

vorinostat DRUG

vorinostat once daily for 12 weeks of therapy

Also known as: Zolinza

vorinostat

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

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

Study Officials

• Ranee Mehra, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: December 16, 2009
• Primary Completion: July 22, 2015
• Study Completion: October 21, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

US (3)