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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00652119
First received: March 31, 2008
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.

Objectives:

Primary study goals:

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

Secondary study goals:

To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing.

To collect overall survival (OS) and progression-free survival (PFS) To determine changes in IP VEGF levels To determine site of first recurrence Information on CA-125 response and clinical response will be descriptive as secondary goals of this study

Exploratory goal:

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of patients who complete entire treatment course (6 cycles of 21 days) [ Time Frame: Total treatment course = 6 cycles (1 cycle is 21 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: February 2008
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel + Carboplatin + Avastin

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.

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.

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.

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.
Other Name: Taxol
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.
Other Name: Paraplatin®
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.
Other Names:
  • Bevacizumab
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

  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. Visible disease on post-operative imaging (recognizing the limitations of postoperative CT scans due to postoperative changes there should be unequivocal CT evidence of residual disease greater than 1cm)
  2. ECOG performance status greater than or equal to 2
  3. Previous chemotherapy for the disease under study
  4. Suboptimal (greater than 1 cm residual disease) cytoreduction
  5. Creatinine greater than 1.5 mg/dL
  6. SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN
  7. Colostomy or ileostomy
  8. 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.)
  9. Known hypersensitivity to E.coli derived products or to any component of Avastin
  10. Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely
  11. History of myocardial infarction within 6 months
  12. History of stroke or transient ischemia attack within 6 months
  13. Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)
  14. Any prior history of hypertensive crisis or hypertensive encephalopathy
  15. Clinically significant peripheral vascular disease
  16. Significant vascular disease (e.g. aortic aneurysm, aortic dissection)
  17. Unstable angina
  18. New York Heart Association (NYHA) grade II or greater congestive heart failure
  19. Evidence of coagulopathy or bleeding diathesis
  20. Known central nervous system disease or brain metastases
  21. 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
  22. 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
  23. Open wound, ulcer, or bone fracture
  24. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and symptoms of bowel obstruction; current dependency on IV hydration or TPN
  25. Pregnant (positive pregnancy test) or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Anil Sood, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00652119     History of Changes
Other Study ID Numbers: 2007-0223
Study First Received: March 31, 2008
Last Updated: August 19, 2013
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
Paraplatin®
Avastin
Bevacizumab
Anti-VEGF monoclonal antibody
rhuMAb-VEGF

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube 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
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Antibodies
Antibodies, Monoclonal
Bevacizumab
Carboplatin
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014