Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Erlotinib and Bevacizumab in Treating Patients With Relapsed or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: University of Arizona
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00696670
  Purpose

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

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab
U.S. FDA Resources
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

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

Primary Outcome Measures:
  • Tumor progression as measured by CA-125 levels [ Designated as safety issue: No ]
  • Objective response rate (complete and partial response according to RECIST criteria) as measured by physical exam and CT scan of the abdomen/pelvis every 2 months [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Correlation between response and EGFR and VEGFR expression levels in tissue blocks obtained prior to study entry [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTC v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2005
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the efficacy and safety of erlotinib hydrochloride and bevacizumab in patients with relapsed or refractory ovarian epithelial cancer or primary peritoneal cancer.
  • To evaluate the objective response rate (confirmed, complete and partial response) and response duration in patients treated with this regimen.

Secondary

  • To assess the effect of this regimen on progression-free survival of these patients.
  • To evaluate the toxicities of this regimen in these patients.
  • To explore, in a preliminary fashion, correlations between response and EGFR and VEGFR expression levels in paraffin embedded tumor tissue obtained during initial laparotomy or laparoscopy.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or pathologically confirmed ovarian epithelial carcinoma or primary peritoneal carcinoma
  • 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

      • Two additional chemotherapy regimens (in addition to primary chemotherapy) are allowed
  • Must have elevated CA-125 OR measurable disease
  • No mixed Müllerian tumors or borderline ovarian tumors

    • History of borderline ovarian tumors that have evolved into higher grade tumors allowed
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Urine protein:creatinine ratio < 1.0
  • Able to take oral medications
  • Able to comply with study and/or follow-up procedures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for up to 3 months after completion of study treatment
  • Baseline blood pressure ≤ 150/100 mm Hg

    • Patients with elevated blood pressure may be eligible provided blood pressure is adequately controlled with anti-hypertensive therapy
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No ongoing problems with bowel obstruction or short bowel syndrome characterized by ≥ grade 2 diarrhea
  • No malabsorption disorders
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No significant traumatic injury within the past 28 days
  • No serious, non-healing wound, ulcer, or bone fracture
  • No other malignancy except nonmelanoma skin cancer
  • No other known severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV)
  • No other unstable or preexisting major medical conditions
  • No life-threatening medical complications related to the malignancy
  • No psychological, familial, sociological, or geographical condition that would preclude study follow-up or compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior hormonal therapy allowed
  • At least 28 days since prior debulking surgery for relapsed disease and recovered
  • More than 28 days since other prior major surgery or open biopsy and recovered
  • More than 28 days since prior chemotherapy, biologic therapy, or any other investigational therapy and recovered
  • More than 4 weeks since prior participation in an experimental drug study
  • More than 7 days since prior minor surgery, fine needle aspiration, or core biopsy
  • No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
  • No concurrent major surgery
  • No concurrent participation in another experimental drug study
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696670

Locations
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        
Sponsors and Collaborators
University of Arizona
Investigators
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
  More Information

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

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

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial 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
Dental Caries
Recurrence
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
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 15, 2009