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Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126542
  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 tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.

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


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: bevacizumab
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma

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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Median progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: April 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with bevacizumab and erlotinib.

Secondary

  • Determine the toxic effects of this regimen in these patients.
  • Determine the median progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 4-12 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

    • Recurrent or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Must have received a platinum-containing chemotherapy regimen for primary disease

    • Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum

      • Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease
  • No evidence of CNS disease, including primary brain tumors or brain metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No history of bleeding diathesis

Hepatic

  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis)
  • Bilirubin normal
  • INR ≤ 1.5 (3 if receiving warfarin)
  • No history of esophageal varices

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min
  • Urine protein < 1+ OR
  • Urine protein < 1,000 mg on 24-hour urine collection OR
  • Urine protein:creatinine ratio < 1.0

Cardiovascular

  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina pectoris
    • Myocardial infarction
  • No clinically significant peripheral artery disease
  • No uncontrolled hypertension
  • No New York Heart Association grade II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No peripheral vascular disease ≥ grade 2

Other

  • Not pregnant
  • No nursing during and for ≥ 3 months after study participation
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after study participation
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
  • No serious or non-healing wound, ulcer, or bone fracture
  • No active infection requiring parenteral antibiotics
  • No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No gastrointestinal tract disease resulting in an inability to take oral medication
  • No significant traumatic injury within the past 28 days
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bevacizumab

Chemotherapy

  • See Disease Characteristics
  • No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy)
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy

Surgery

  • More than 4 weeks since prior major surgical procedure or open biopsy
  • More than 1 week since prior core biopsy
  • No prior surgery affecting absorption
  • No concurrent major surgery

Other

  • Recovered from prior therapy
  • No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy
  • No prior erlotinib
  • At least 30 days since prior investigational drugs
  • More than 1 month since prior thrombolytic agents
  • Concurrent warfarin allowed provided the following criteria are met:

    • Patient is on a therapeutic stable dose of warfarin
    • INR ≤ 3
    • No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126542

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology/Hematology Associates of Central Illinois, P.C.
Ottawa, Illinois, United States, 61350
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000434820, UCCRC-13576A, NCI-6759
Study First Received: August 2, 2005
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00126542  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Erlotinib
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Bevacizumab
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Carcinoma
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009