Clinical trial · Interventional
Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): toxicities
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat
- description
- All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
- interventionNames
- Drug: Vorinostat
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 2 years or 24 months
- description
- Clinical response was assessed by clinical, serologic, and radiographic means.
Secondary outcomes (1)
- measure
- Number of Participants With Progression Free Survival (PFS) up to 24 Months
- timeFrame
- 2 years or 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available