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Bevacizumab and Docetaxel in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2009
First Received: July 17, 2007   Last Updated: May 21, 2009   History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00504257
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to kill tumor cells or stop them from growing.

Giving bevacizumab together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: bevacizumab
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival (PFS) at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of PFS [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Safety profile [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: February 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival (PFS) and the overall PFS of the investigational treatment regimen.

Secondary

  • Determine the response rate (RR) of the investigational treatment regimen.
  • Determine duration of response.
  • Assess the safety profile of the investigational treatment regimen of bevacizumab and weekly docetaxel in progressive or recurrent ovarian cancer within 12 months of platinum-based chemotherapy regimen.
  • Estimate the overall survival (OS) of patients treated with the investigational treatment regimen.

OUTLINE: This is a multicenter study.

Bevacizumab IV over 30-90 minutes is administered every 3 weeks (day 1 of 21-day cycle) in combination with docetaxel IV over 1 hour each week (days 1and 8 of 21-day cycle) for at least 8 courses in the absence of disease progression or toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Pathologically confirmed ovarian epithelial cancer, peritoneal serous cancer, or fallopian tube cancer

    • Patient's disease recurrence or progression occurs between 0 to 12 months (1 to 356 days) from prior platinum-containing chemotherapy regimen
  • Patient may have received up to three prior chemotherapy regimens for the treatment of this malignancy

    • Patients who may have received prior treatment with paclitaxel and/or a platinum compound will be allowed
    • Rechallenge with the same platinum-based regimen is considered 1 prior regimen
    • Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen
    • Hormonal therapy (i.e. progesterones, estrogens, anti-estrogens, aromatase inhibitors) will not be considered a prior chemotherapy regimen
  • Measurable or evaluable disease either by the GOG Response Evaluation Criteria in Solid Tumors (RECIST) or CA 125 criteria

    • RECIST Criteria - Patients must have at least one lesion that can be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan

      • If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
    • CA 125 Criteria - CA 125 ≥ 70 on two occasions at least one week apart

      • Subject must not have received any mouse antibodies in the past and must be at least 28 days from major surgery prior to evaluation of CA 125

Exclusion criteria:

  • Presence of central nervous system or brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status ≤ 2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ upper limit of normal (ULN)
  • AST and ALT and alkaline phosphatase must be within the following range:

    • AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN
    • AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
    • AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
  • Negative pregnancy test
  • Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months following the completion of treatment

Exclusion criteria:

  • Peripheral neuropathy ≥ grade 2
  • History of a severe hypersensitivity reaction to docetaxel, bevacizumab, or to other drugs formulated with polysorbate (Tween) 80
  • Blood pressure of > 150/100 mm Hg
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Significant traumatic injury within 28 days prior to Day 0
  • Pregnant (positive pregnancy test) or lactating
  • Urine protein:creatinine ratio ≥ 1.0
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, ulcer, or bone fracture
  • Evidence of malignancy in the last 5 years, other than non-melanoma cutaneous carcinomas
  • History of hemoptysis (bright red blood of ½ teaspoon or more) within last 3 months
  • Patients believed to possibly be at higher than average risk of perforation, including symptoms or findings of partial or complete bowel obstruction, history of fistula, patients requiring parenteral nutrition and hydration, and those with history of prior perforation due to tumor or perforation within last 6 months from other causes will be excluded from study

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • At least 4 weeks since major surgery, with full recovery
  • At least 3 weeks since radiotherapy, with full recovery

    • Measurable disease must be completely outside of the radiation port

Exclusion criteria:

  • Prior treatment with docetaxel or bevacizumab
  • Patients may not receive study drug until at least 28 days from prior chemotherapy
  • Major surgical procedure or open biopsy within 28 days prior to Day 0
  • Minor surgical procedures such as fine-needle aspirations or core biopsies within 7 days prior to Day 0
  • Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the ovarian cancer

    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment
    • Continuation of hormonal replacement therapy is allowed
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
  • Anticipation of need for major surgical procedure during the course of the study
  • No concurrent irradiation of an indicator lesion
  • No other concurrent chemotherapy or immunotherapy
  • Also see Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504257

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese     800-456-7121     canceranswers@moffitt.org    
United States, North Carolina
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Robert M. Wenham, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida ( Robert M. Wenham )
Study ID Numbers: CDR0000555026, MCC-14920, MCC-105366c
Study First Received: July 17, 2007
Last Updated: May 21, 2009
ClinicalTrials.gov Identifier: NCT00504257     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Bevacizumab
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Angiogenesis Inhibitors
Fallopian Tube Neoplasms
Recurrence
Carcinoma
Docetaxel
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on September 11, 2009