Study of Bevacizumab/Doxil in Treatment of Platinum-Resistant/Refractory Ovarian Cancer (CA)

This study has been completed.
Sponsor:
Collaborators:
Genentech
New York University School of Medicine
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00945139
First received: July 21, 2009
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.


Condition Intervention Phase
Ovarian Cancer
Drug: Doxil and Avastin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab and Doxil in the Treatment of Platinum-Resistant or Refractory Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Progression Free Survival (PFS) is the primary outcome measure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Objective responses will be assessed by RECIST criteria, and by CA125 responses as determined by Rustin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate (ORR) will be measured by assessing complete responses (CR) and partial responses (PR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Clinical benefit will be assessed by adding stable disease (SD) to ORR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Doxil and Avastin
    Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression
    Other Names:
    • Doxorubicin
    • Bevacizumab
Detailed Description:

Avastin:

Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Avastin has been approved for the treatment of colorectal cancer and lung cancer. Avastin is investigational for the treatment of ovarian cancer and has not been approved by the United States Food and Drug Administration (FDA) for this use.

Avastin is thought to work by attaching to a protein called vascular endothelial growth factor (VEGF) to block its action. VEGF plays a role in the formation of both normal and abnormal blood vessels. It is present in normal tissues, but is produced in excess by most solid cancers (tumors). In cancer, VEGF helps blood vessels bring nutrients to tumor cells, allowing the tumor cells to grow. In laboratory studies with human cancer cells grown in animals, Avastin has been shown to prevent or slow the growth of different types of cancer cells by blocking the effects of VEGF.

Doxorubicin:

Doxorubicin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer. Doxorubicin has been approved by the FDA to treat cancers of the head, neck, cervix, vagina, testes, prostate, uterus and Ewing's tumor.

  Eligibility

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

Inclusion Criteria:

  • Patients must be platinum resistant
  • Patients will be included in the study based on the following criteria:

    • No prior anthracycline use
    • PS less or equal 2
    • Lab values within certain limits (ANC greater 1000, platelets greater 100,000; ALT, AST 2 time ULN, creatinine less 2.0)
    • No more than 3 prior chemotherapy regimens, only 2 of which can have included platinum-containing regimens
    • Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria:

  1. Disease-Specific Exclusions:

    • Evidence of complete or partial bowel obstruction
    • Need for IV hydration or TPN
    • Greater 2 prior abdominal surgeries
    • History of gastrointestinal perforation
    • Gastrointestinal perforation due to any other cause within the last 6 months
  2. General Medical Exclusions:

    • Inability to comply with study and/or follow-up procedures
    • Life expectancy of less than 12 weeks
    • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
  3. Avastin-Specific Exclusions

    • Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure greater 100 mmHg on antihypertensive medications)
    • Any prior history of hypertensive crisis or hypertensive encephalopathy
    • New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
    • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
    • History of stroke or transient ischemic attack within 6 months prior to study enrollment
    • Known CNS disease
    • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
    • Symptomatic peripheral vascular disease
    • Evidence of bleeding diathesis or coagulopathy
    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
    • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
    • History of abdominal fistula, or intra-abdominal abscess within 6 months prior to study enrollment
    • Serious, non-healing wound, ulcer, or bone fracture
    • Proteinuria at screening as demonstrated by either:

      • Urine protein:creatinine (UPC) ratio 1.0 at screening OR
      • Urine dipstick for proteinuria greater or equal 2plus (patients discovered to have greater or equal 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate less or equal 1g of protein in 24 hours to be eligible)
    • Known hypersensitivity to any component of Avastin
    • Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential
  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: NCT00945139

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
United States, New York
New York University Cancer Institute
New York City, New York, United States, 10016
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Genentech
New York University School of Medicine
Investigators
Principal Investigator: Claire F. Verschraegen, M.D. University of New Mexico
Study Director: Franco Muggia, MD New York University Cancer Institute
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00945139     History of Changes
Other Study ID Numbers: INST AVF3911s
Study First Received: July 21, 2009
Last Updated: November 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014