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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652119
Recruitment Status : Active, not recruiting
First Posted : April 3, 2008
Last Update Posted : August 28, 2017
Genentech, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


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 or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Drug: Paclitaxel Drug: Carboplatin Drug: Avastin Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : February 2008
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Patients Who Complete Entire Treatment Course [ Time Frame: Total treatment course = 6 cycles (1 cycle is 21 days) ]
    Rate of completers estimated along with a 95% confidence interval to evaluate the tolerability of this regimen.

Secondary Outcome Measures :
  1. Systemic Exposure to Paclitaxel and Carboplatin [ Time Frame: Second and fourth 21 day cycle ]
    Primary objective of pharmacokinetic studies is to determine whether rate and extent absorption of paclitaxel and carboplatin into systemic circulation when given by the intraperitoneal port (IP) route is influenced by concurrent administration of Avastin by vein. Sampling to define plasma concentration time courses of paclitaxel and carboplatin performed during second cycle without Avastin and fourth cycle of therapy with Avastin. Pharmacokinetic parameters and variables calculated according to standard equations. Concentration-time profiles of carboplatin and its metabolites analyzed by noncompartmental methods and/or nonlinear least squares regression. Mean values of pharmacokinetic parameters statistically compared using the two-tailed t-test.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652119

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
University of Texas MD 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, Inc.
National Cancer Institute (NCI)
Principal Investigator: Anil Sood, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00652119     History of Changes
Other Study ID Numbers: 2007-0223
NCI-2010-00091 ( Registry Identifier: NCI CTRP )
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Carcinoma of Mullerian Origin
Anti-VEGF monoclonal antibody

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents