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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00126542 |
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 |
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 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No arterial thromboembolic event within the past 6 months, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Concurrent warfarin allowed provided the following criteria are met:
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 |
Study Chair: | Gini F. Fleming, MD | University of Chicago |
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 |
recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
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 |
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 |