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

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Carolyn N. Krasner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181701
First received: September 12, 2005
Last updated: December 4, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181701

Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Carolyn Krasner, MD Massachusetts General Hospital
  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 April 17, 2014