Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00731952
First received: August 6, 2008
Last updated: February 2, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Velcade and Vorinostat
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 30 days post surgical resection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: Day 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2006
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Velcade and Vorinostat
Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.
Drug: Velcade and Vorinostat
Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.

  Eligibility

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

Inclusion Criteria

  • Histologically confirmed NSCLC (clinical stage IB, IIA, IIB, IIIA, or selected IIIB (T4N0-1M0)), exclusive of patients with MPE
  • Planned surgical resection
  • Age > 18 years
  • ECOG performance status 0-1
  • Patient has adequate organ and marrow function, as defined below:
  • Patient has a platelet count of > 100 x 109/L
  • Patient has a WBC count of > 3.5 x 109/L
  • Patient has an absolute neutrophil count of > 1.5 x 109/L
  • Patient has hemoglobin of > 8 gm/dl. Patients may receive transfusions, erythropoietin or darbepoetin to achieve this hemoglobin level.
  • Patient has a serum creatinine of < 2.0 mg/dL
  • Patient has AST < 1.5 x ULN
  • Patient has bilirubin < 1.5 x ULN
  • Patient has INR < 1.5 x ULN
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male subject agrees to use an acceptable method for contraception for the duration of the study

Exclusion Criteria

  • Previous chemotherapy or radiation therapy within 5 years before enrollment.
  • Prior history of treatment for a known NSCLC within the last 5 years of if > 5 years but still thought by the investigator to represent recurrent disease.
  • Prior exposure to either Velcade or Vorinostat
  • Prior exposure to any HDAC inhibitors within the previous 30 days. Patients who have received such agents for other indications may enroll after 30-day wash-out period. Subject may not take any other HDAC inhibitor during this trial.
  • Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to VELCADE, boron or mannitol.
  • Patient has known allergy to any component of Vorinostat (MK-0683)
  • Female subject is pregnant or breast-feeding. Confirm by a negative serum B-hCG pregnancy test result obtained during screening (not required for post-menopausal or surgically sterilized women).
  • Patient is participating or has participated in another investigational trial, and has received other investigational drugs/therapies within 30 days of enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Patient has history of GI surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs.
  • Subject is currently taking herbal remedy and/or homeopathic agent which cannot (or the patient is unwilling) be discontinued during the conduct of this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731952

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: David R Jones, MD University of Virginia
  More Information

No publications provided

Responsible Party: David R. Jones, University of Virginia
ClinicalTrials.gov Identifier: NCT00731952     History of Changes
Other Study ID Numbers: 12472
Study First Received: August 6, 2008
Last Updated: February 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
surgically resectable

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
Bortezomib
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protease Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014