Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00696670 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving erlotinib together with bevacizumab works in treating patients with relapsed or refractory ovarian epithelial cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: bevacizumab Drug: erlotinib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | PHASE II OPEN-LABEL TRIAL OF ERLOTINIB (TARCEVA) AND BEVACIZUMAB (AVASTIN®) IN WOMEN WITH ADVANCED OVARIAN CANCER |
Estimated Enrollment: | 40 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral erlotinib hydrochloride once daily and bevacizumab IV over 30-90 minutes once every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then periodically thereafter.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed or refractory disease after primary therapy
Relapsed within 6 months after completion of prior taxane (paclitaxel or docetaxel)- and platinum (cisplatin or carboplatin)-based chemotherapy OR best response during 1 or 2 chemotherapy treatments was increasing disease
No mixed Müllerian tumors or borderline ovarian tumors
PATIENT CHARACTERISTICS:
Baseline blood pressure ≤ 150/100 mm Hg
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: David S. Alberts, MD 866-278-1554 | |
Premiere Oncology of Arizona | Recruiting |
Scottsdale, Arizona, United States, 85260 | |
Contact: Michael S. Gordon, MD 480-860-5000 | |
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Recruiting |
Scottsdale, Arizona, United States, 85258 | |
Contact: David S. Mendelson, MD 480-323-1350 | |
United States, Connecticut | |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06360-2875 | |
Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can 800-579-7822 |
Principal Investigator: | David S. Alberts, MD | University of Arizona |
Principal Investigator: | Setsuko K. Chambers, MD | University of Arizona |
Principal Investigator: | Kenneth D. Hatch, MD | University of Arizona |
Responsible Party: | Arizona Cancer Center at University of Arizona Health Sciences Center ( David Samuel Alberts ) |
Study ID Numbers: | CDR0000597512, UARIZ-05-0178-01, UARIZ-HSC0547, UARIZ-SRC17862, GENENTECH-UARIZ-05-0178-01, UARIZ-AZCC-02 |
Study First Received: | June 12, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00696670 |
Health Authority: | Unspecified |
recurrent ovarian epithelial 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 Dental Caries Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy 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 |