Status:
COMPLETED
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 adm...
Detailed Description
Patients will have an intraperitoneal port placed at the time of their initial surgery or at a second procedure prior to cycle 2 of chemotherapy. Patients will receive a total of 6 cycles of therapy ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00181701
Start Date
October 1 2004
End Date
May 1 2006
Last Update
April 14 2022
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