Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Gynecologic Oncology Associates.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gynecologic Oncology Associates
Collaborator:
Merck
Information provided by:
Gynecologic Oncology Associates
ClinicalTrials.gov Identifier:
NCT00976183
First received: September 10, 2009
Last updated: June 24, 2011
Last verified: June 2011
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Purpose
Since the mortality rates for patients with advanced ovarian carinoma are high, the most likely way to improve progression free and overall survival is with maximal "upfront" therapy (Morrow & Curtin, 1998). Currently, no triplet regimen has demonstrated compelling superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms |
Drug: Vorinostat |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Open-Label, Non-Randomized, Pilot Study of Weekly Paclitaxel, Every Four-week Carboplatin and Oral Vorinostat for Patients Newly Diagnosed With Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer |
Resource links provided by NLM:
Further study details as provided by Gynecologic Oncology Associates:
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: 2 years or 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Progression Free Survival [ Time Frame: 2 years or 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 43 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vorinostat
All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
|
Drug: Vorinostat
Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Other Name: suberoylanilide hydroxamic acid (SAHA)
Drug: Vorinostat
Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Other Name: suberoylanilide hydroxamic acid (SAHA)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
- Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
- If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
- Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.
- Karnofsky performance status > 50%.
- Subjects who have signed an institutional review board (IRB) approved informed consent form.
Exclusion Criteria:
- Subjects with epithelial ovarian cancer of low malignancy potential.
- Subjects with septicemia, severe infection, or acute hepatitis.
- Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976183
Contacts
| Contact: Katrina Lopez | 949-642-5165 | katrinal@gynoncology.com |
| Contact: bram goldstein, PhD | 949-642-5165 | bram@gynoncology.com |
Locations
| United States, California | |
| Gynecologic Oncology Associates | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Katrina Lopez, CCRC 949-642-5165 Katrinal@gynoncology.com | |
| Principal Investigator: John Micha, MD | |
Sponsors and Collaborators
Gynecologic Oncology Associates
Merck
Investigators
| Principal Investigator: | John Micha, MD | Gynecologic Oncology Associates |
More Information
No publications provided
| Responsible Party: | John Micha, MD, Gynecologic Oncology Associates |
| ClinicalTrials.gov Identifier: | NCT00976183 History of Changes |
| Other Study ID Numbers: | GOA-TCOV |
| Study First Received: | September 10, 2009 |
| Last Updated: | June 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Gynecologic Oncology Associates:
|
ovarian cancer gynecologic oncology vorinostat treatment |
Additional relevant MeSH terms:
|
Neoplasms Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Vorinostat |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Histone Deacetylase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013