Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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