Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ovarian Carcinoma |
Drug: Paclitaxel Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
- To determine the efficacy of this regimen as defined by surgical response rate
| Estimated Enrollment: | 46 |
| Study Start Date: | October 2004 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Carolyn N. Krasner, MD, PI, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181701 History of Changes |
| Other Study ID Numbers: | 04-100 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Ovarian cancer Epithelial carcinoma of mullerian origin Intraperitoneal paclitaxel |
Intraperitoneal carboplatin Primary peritoneal carcinoma Tubal carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013