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Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced Non-small Cell Lung Cancer

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Trial Information

Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)


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.


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
Exclusion Criteria:

- Chemotherapy or radiotherapy 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

toxicity assessments will occur weekly

Safety Issue:

Yes

Principal Investigator

Ranee Mehra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

FER-TH-031

NCT ID:

NCT01059552

Start Date:

December 2009

Completion Date:

July 2013

Related Keywords:

  • Locally Advanced Non-Small Cell Lung Cancer
  • lung cancer
  • locally advanced lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
Moffitt Cancer Cetner Tampa, Florida  33612