Clinical trial · Interventional
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin
A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs are administered intravenously but a number of trials have shown that injecting drugs into the abdominal cavity, or intraperitoneally, have shown promising results.
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 Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
Secondary outcomes (1)
- measure
- To determine the efficacy of this regimen as defined by surgical response rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma * Stage II or III disease * Patient must have undergone surgical staging and debulking with optimal cytoreduction * Able and willing to undergo a second look staging laparotomy * 18 years of age or older * Adequate bone marrow function with an Absolute Neutrophil Count (ANC) \> 2,500 and platelets \> 100,000/mm3 * ECOG performance status less than or equal to 2 Exclusion Criteria: * Disease outside the abdominal cavity * Stage IV disease, including abdominal wall, visceral and/or pleural involvement * Previous chemotherapy for ovarian cancer * Suboptimal cytoreduction * Creatinine \> 1.5 mg/dl * History of recent Myocardial Infarction or congestive heart failure within 6 months of surgery * SGOT \> 2x Upper Limit of Normal (ULN), bilirubin \> 1.5 x ULN * Colostomy or ileostomy * Concurrent invasive malignancy * Known hypersensitivity to E. coli derived products * Active psychiatric or mental illness precluding informed consent
References
Publications (0)
Data not yet available