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A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Patient must have a histologically-confirmed metastatic or locally advanced non-small
cell lung cancer that has not been previously treated with systemic chemotherapy or
has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant
chemotherapy if the last dose was at least 6 months prior to study enrollment

Exclusion Criteria:

- Patient who has had chemotherapy, radiotherapy, or biological therapy prior to
entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for
treatment of a tumor

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin

Outcome Description:

DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.

Outcome Time Frame:

every 21 days (every cycle), up to 126 days (6 cycles)

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

France: Ministry of Health

Study ID:

MK-0683-058

NCT ID:

NCT00423449

Start Date:

March 2007

Completion Date:

April 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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