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

NCT00181701 | Completed Phase 2 DMC

• 1 other identifier: 04-100
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Carcinoma

Keywords

Ovarian cancer; Epithelial carcinoma of mullerian origin; Intraperitoneal paclitaxel; Intraperitoneal carboplatin; Primary peritoneal carcinoma; Tubal carcinoma

Outcome Measures

Primary Outcomes (1)

• To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally

Secondary Outcomes (1)

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

Interventions

Paclitaxel DRUG

Carboplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Richard T Penson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director Medical Gynecologic Oncology

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: April 14, 2022

Record last verified: 2022-04