A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Condition(s) targeted: Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer

Intervention: vorinostat (Drug); Comparator : placebo (unspecified) (Drug); paclitaxel (Drug); carboplatin (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin.

Revised (20-Dec-2007)

Official title: A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Overall survival

Secondary outcome: Progression Free Survival and Response Rate

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females at least 18 years of age who have confirmed diagnosis of Non-small

Cell Lung Cancer

- Patients with no prior treatment for lung cancer except patients at least 12 months

from prior adjuvant therapy

- Adequate bone marrow,kidney and liver function.

- Must be recovered and at least 4 weeks from major surgery or radiation treatment

- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1

- Men and women must agree to use birth control during the study

- Women able to have children must have a negative pregnancy test 14 days before study

enrollment

Exclusion Criteria:

- Patients with prior treatment with other investigational agents less than 4 weeks

before study enrollment

- Pregnant or nursing female patients.

- Patients who are HIV positive

- Patients who have Hepatitis A, B, or C

- Patients unable to take study medication by mouth

- Patients with untreated brain cancer

- Patient eligible for treatment with bevacizumab

Toll Free Number, Phone: 1-888-577-8839

Merck Sharp & Dohme (Australia) Pty Ltd., South Granville NSW 2142, Australia; Recruiting
David Woolner, Phone: 64-9523-6075

Merck Sharp & Dohme, Glostrup 2600, Denmark; Recruiting
Christina Wengel, Phone: 45-43-28-77-90

MSD Finland Oy, Espoo 2151, Finland; Recruiting
Eero Helve, Phone: 358 9 804 65 20

Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536

MSD Pharmaceuticals Private Ltd., New Delhi 110011, India; Recruiting
Naveen Rao, Phone: 91 11 555 13086

Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187

MSD Korea Ltd., Seoul 121-705, Korea, Republic of; Recruiting
Paul Jang, Phone: 822-8383-0024

Merck Sharp & Dohme (I.A.) Corp, Selangor 46300, Malaysia; Recruiting
Nazrin Azli, Phone: 603-79662848

Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700

Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-095-941-8264

Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34 91 3210726

MSD (Thailand) Ltd., Bangkok 10330, Thailand; Recruiting
Suchai Kitsiripornchai, Phone: 66-2-255-5090

Call for Information, Muscle Shoals, Alabama 35661, United States; Recruiting

Call for Information, Glendale, Arizona 85304, United States; Recruiting

Call for Information, West Hollywood, California 90069, United States; Recruiting

Call for Information, Santa Rosa, California 95403, United States; Recruiting

Call for Information, San Diego, California 92120, United States; Recruiting

Call for Information, Glendora, California 91740, United States; Recruiting

Call for Information, Fountain Valley, California 92708, United States; Recruiting

Call for Information, Alhambra, California 91801, United States; Recruiting

Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400

Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825

Call for Information, New Port Richey, Florida 34655, United States; Recruiting

Call for Information, New Port Richey, Florida 34652, United States; Recruiting

Call for Information, Miami, Florida 33179, United States; Recruiting

Call for Information, Jacksonville, Florida 32209, United States; Recruiting

Call for Information, Brooksville, Florida 34613, United States; Recruiting

MSD (Pty) LTD South Africa, Midrand, Gauteng 1685, South Africa; Recruiting
Beverley Cowper, Phone: 27 11 655-3036

Call for Information, Augusta, Georgia 30912-0000, United States; Recruiting

Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452341

Call for Information, Chicago, Illinois 60611, United States; Recruiting

Call for Information, New Albany, Indiana 47150-6809, United States; Recruiting

Call for Information, Wichita, Kansas 67214, United States; Recruiting

Call for Information, Hazard, Kentucky 41701, United States; Recruiting

Merck Sharp & Dohme, Peru S.R.L., Surquillo, Lima LIMA 34, Peru; Recruiting
Jorge Vinces, Phone: 511-411-5933

Call for Information, Baltimore, Maryland 21231-1000, United States; Recruiting

Call for Information, Southgate, Michigan 48195, United States; Recruiting

Call for Information, Ann Arbor, Michigan 48106, United States; Recruiting

Call for Information, St. Louis, Missouri 63110, United States; Recruiting

Call for Information, Las Vegas, Nevada 89135, United States; Recruiting

Call for Information, Lebanon, New Hampshire 03756, United States; Recruiting

Call for Information, Teaneck, New Jersey 07666, United States; Recruiting

Call for Information, Bronx, New York 10467, United States; Recruiting

Call for Information, Cleveland, Ohio 44195, United States; Recruiting

Call for Information, Philadelphia, Pennsylvania 19111, United States; Recruiting

Call for Information, Hershey, Pennsylvania 17033-0850, United States; Recruiting

Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Francois Bertrand, Phone: 1-514-428-2641

Call for Information, Greenville, South Carolina 29615, United States; Recruiting

Call for Information, Memphis, Tennessee 38104, United States; Recruiting

Call for Information, Germantown, Tennessee 38138, United States; Recruiting

Call for Information, Richmond, Virginia 23230, United States; Recruiting

Call for Information, Tacoma, Washington 98405, United States; Recruiting

Call for Information, Lacey, Washington 98503, United States; Recruiting

Call for Information, Milwaukee, Wisconsin 53226, United States; Recruiting

Call for Information, Madison, Wisconsin 53792-0000, United States; Recruiting

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: May 2007
Last updated: June 11, 2008