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Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, March 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Genentech
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00652119
  Purpose

Primary Objectives:

  1. To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin.
  2. To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents.

Secondary Objectives:

  1. To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing.
  2. To collect overall survival (OS) and progression-free survival (PFS).
  3. To determine changes in IP VEGF levels.
  4. To determine site of first recurrence.
  5. Information on CA-125 response and clinical response will be descriptive as secondary goals of this study.

Exploratory Objective:

1. To estimate proportion of patients completing entire course of treatment.


Condition Intervention
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Drug: Paclitaxel
Drug: Carboplatin
Drug: Avastin

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Carboplatin    Paclitaxel    Bevacizumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Pilot Trial of Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   46
Study Start Date:   February 2008
Estimated Primary Completion Date:   February 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Paclitaxel + Carboplatin + Avastin
Drug: Paclitaxel
Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
Drug: Carboplatin
Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
Drug: Avastin
Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
  2. Stage III or IV disease. Stage IV disease by virtue of pleural effusions is allowed but stage IV disease with visceral metastases e.g. lung, liver or abdominal wall is NOT ELIGIBLE. Please discuss any eligibility concerns directly with the P.I., Dr. Carolyn Krasner.
  3. Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.
  4. No significant intra-abdominal adhesions or other contraindication to IP port placement.
  5. Patients must give written informed consent.
  6. Patient must be age 18 years or older.
  7. Adequate bone marrow function with an ANC greater that 2,500 and Platelets greater than 100,000 cubic millimeters.
  8. No proteinuria or less than +1; if greater, 24-hour urine collection must be performed to document less than or equal to 1gm/24 hours of protein.
  9. ECOG performance status less than or equal to 1.

Exclusion Criteria:

  1. ECOG performance status greater than or equal to 2
  2. Previous chemotherapy
  3. Suboptimal (greater than 1 cm residual disease) cytoreduction
  4. Creatinine greater than 1.5 mg/dL
  5. SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN
  6. Colostomy or ileostomy
  7. Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium.)
  8. Known hypersensitivity to E.coli derived products or to any component of Avastin
  9. Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely
  10. History of myocardial infarction within 6 months
  11. History of stroke or transient ischemia attack within 6 months
  12. Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)
  13. Any prior history of hypertensive crisis or hypertensive encephalopathy
  14. Clinically significant peripheral vascular disease
  15. Significant vascular disease (e.g. aortic aneurysm, aortic dissection)
  16. Unstable angina
  17. New York Heart Association (NYHA) grade II or greater congestive heart failure
  18. Evidence of coagulopathy or bleeding diathesis
  19. Known central nervous system disease or brain metastases
  20. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 28 (first dose of Avastin), anticipation of need for major surgical procedure during the course of the study
  21. Minor surgical procedures such as fine needle aspirations or core biopsies or laparoscopy for IP catheter placement within 7 days prior to cycle 2 day 8
  22. Open wound, ulcer, or bone fracture
  23. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and symptoms of bowel obstruction; current dependency on IV hydration or TPN
  24. Pregnant (positive pregnancy test) or lactating
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652119

Contacts
Contact: Judith Wolf, MD     713-792-7310    

Locations
United States, Maryland
Johns Hopkins Hospital     Recruiting
      Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Fox Chase Cancer Center     Recruiting
      Philadelphia, Pennsylvania, United States, 19111
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Judith Wolf, MD            
United States, Washington
University of Washington     Recruiting
      Seattle, Washington, United States, 98195

Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech

Investigators
Principal Investigator:     Judith Wolf, MD     U.T.M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T.M.D. Anderson Cancer Center ( Judith Wolf, MD/Associate Professor )
Study ID Numbers:   2007-0223
First Received:   March 31, 2008
Last Updated:   March 31, 2008
ClinicalTrials.gov Identifier:   NCT00652119
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer  
Peritoneal Cancer  
Fallopian Tube Cancer  
Carcinoma of Mullerian Origin  
Paclitaxel  
Taxol
Carboplatin
Avastin
Bevacizumab

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Bevacizumab
Ovarian Diseases
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Fallopian tube cancer
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 10, 2008




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