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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00181701

Collaborator

Dana-Farber Cancer Institute (Other), Brigham and Women's Hospital (Other)

Enrollment

Duration (Months)

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Carcinoma	Drug: Paclitaxel Drug: Carboplatin	Phase 2

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally []

Secondary Outcome Measures

To determine the efficacy of this regimen as defined by surgical response rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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