A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
18 Years
N/A
Female
Ovarian Carcinoma
Trial Information
A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
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 as an outpatient. They will have 1
cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin
intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle.
Each cycle is 21 days long.
To help reduce the chance of an allergic reaction, patients will also take decadron tablets
orally before paclitaxel administration.
About 1 liter of standard salt solution will be injected through a catheter into the
abdominal cavity with each treatment to help distribute the drugs throughout the abdominal
cavity.
"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last
chemotherapy course (cycle 6) if the patient is in complete clinical remission. This
surgery is done to see how effective the chemotherapy was.
Tests and procedures will be done throughout the treatment to see how the cancer is
responding and to monitor for safety purposes. These tests and procedures include routine
history and physical exam, neurological exam, and routine blood tests. As part of this
study we will also be checking the amount of paclitaxel and carboplatin in the blood.
Participation in this study will last approximately 6 months as long as the treatment is
well tolerated, there are no serious side effects and the disease has not progressed.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
Principal Investigator
Carolyn Krasner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
04-100
NCT ID:
NCT00181701
Start Date:
October 2004
Completion Date:
May 2006
Related Keywords:
- Ovarian Carcinoma
- Ovarian cancer
- Epithelial carcinoma of mullerian origin
- Intraperitoneal paclitaxel
- Intraperitoneal carboplatin
- Primary peritoneal carcinoma
- Tubal carcinoma
- Carcinoma
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|
