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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Brigham and Women's Hospital Massachusetts General Hospital Merck |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00910000 |
Purpose
The purpose of this research study is to: 1) Determine the highest dose of the drug vorinostat that can be given safely in combination with carboplatin and gemcitabine and 2) determine how long the participant's cancer will respond to the combination of vorinostat, carboplatin and gemcitabine. Vorinostat is a type of drug called a histone deacetylase inhibitor (HDAC inhibitor). HDAC inhibitors interact with chromosomes in the cancer cell and cause cancer cells to stop growing. Vorinostat has shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may enhance the anti-cancer effects of carboplatin.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer |
Drug: Vorinostat Device: Carboplatin Drug: Gemcitabine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase IB/II Study of Combination Vorinostat, Carboplatin and Gemcitabine Plus Vorinostat Maintenance in Women With Recurrent, Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer |
| Estimated Enrollment: | 54 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Dose Level 1: Experimental |
Drug: Vorinostat
Taken orally once a day in the AM for the first two weeks of each three-week cycle. Dose will depend upon when participant enters into the clinical trial
Device: Carboplatin
Given intravenously on day 1 of every three week cycle
Drug: Gemcitabine
Given intravenously on day and day 8 of every three week cycle
|
| Dose Level 2: Experimental |
Drug: Vorinostat
Taken orally once a day in the AM for the first two weeks of each three-week cycle. Dose will depend upon when participant enters into the clinical trial
Device: Carboplatin
Given intravenously on day 1 of every three week cycle
Drug: Gemcitabine
Given intravenously on day and day 8 of every three week cycle
|
| Dose Level 3: Experimental |
Drug: Vorinostat
Taken orally once a day in the AM for the first two weeks of each three-week cycle. Dose will depend upon when participant enters into the clinical trial
Device: Carboplatin
Given intravenously on day 1 of every three week cycle
Drug: Gemcitabine
Given intravenously on day and day 8 of every three week cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ursula A. Matulonis, MD | 617-632-2334 |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Ursula A. Matulonis, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Richard T. Penson, MD | |
| Principal Investigator: | Ursula A. Matulonis, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Ursula A. Matulonis, MD ) |
| Study ID Numbers: | 09-026 |
| Study First Received: | May 26, 2009 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00910000 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
carboplatin gemcitabine vorinostat |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Sensory System Agents |
Therapeutic Uses Peritoneal Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Vorinostat Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Carboplatin Abdominal Neoplasms Protective Agents |