Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer

NCT00130520 | Completed Phase 2 Results DMC

• 1 other identifier: HSC #05-47;AVF3117s
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).

Conditions

Ovarian Neoplasms

Keywords

advanced ovarian cancer; refractory ovarian cancer; primary peritoneal cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response (Complete Partial, Stable and Progression)

  Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria

  06.16.2005 to 10.05.2009

• Median Response Duration (Weeks)

  Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration)

  1 week to 96 weeks

Secondary Outcomes (1)

• Progression Free Survival(PFS)

  June 2005 to October 5, 2009

Study Arms (1)

open label

EXPERIMENTAL

Drug: bevacizumab; Drug: erlotinib

Interventions

bevacizumab DRUG

10mg/kg every two weeks IV-bevacizumab

Also known as: Avastin

open label

erlotinib DRUG

150mg daily by mouth-erlotinib

Also known as: Tarceva

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma.
• Relapsed after prior therapy with taxane and platinum-based therapy, within 6 months of completing, or had a best response of stable disease during no more than two prior chemotherapy treatments with a platinum (either cisplatin or carboplatin) and a taxane (paclitaxel or docetaxel). These agents may have been administered concurrently or sequentially. Besides the primary chemotherapy, two additional chemotherapy regimens are allowed. Hormonal therapy is allowed and will not be counted as a chemotherapy regimen.
• Up to one year of consolidation treatment with intraperitoneal and intravenous administered chemotherapy drugs to consolidate a clinical complete remission is allowed.
• Patients must have elevated CA-125 or measurable disease.
• For patients who do not have RECIST measurable disease, an elevated CA-125 (greater than two times the institutional upper limit of normal) will be required for enrollment.
• Debulking surgery for relapsed disease is allowed but must be completed at least 28 days prior to the first day of study therapy. Patient must have recovered from all side effects of surgery including a completely healed surgical incision.
• Patient must have a Zubrod performance status of 0-1.
• Patient must have adequate hepatic function as defined by:
• a serum bilirubin ≤1.5 x the institutional upper limit of normal (IULN),
• SGOT or SGPT ≤2.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy
• Patient must have an adequate renal function as defined by:
• a serum creatinine ≤1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy and a urine protein:creatinine (UPC) ratio of ≤ 1.0.
• Patients must be able to take oral medications
• Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
• Patients must have the following hematological criteria:

You may not qualify if:

• Subjects with mixed mullerian tumors and borderline ovarian tumors are excluded. Patients with a history of borderline ovarian tumors that have evolved into higher grade tumors will be eligible.
• The patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
• Patient must not be pregnant or nursing because bevacizumab or erlotinib maybe harmful to the developing fetus and newborn. Women of reproductive potential must have a negative serum pregnancy test within 7 days prior to study consent. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
• Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
• Except for cancer-related abnormalities, patients should not have unstable or preexisting major medical conditions.
• Patients should not have any medical life-threatening complications of their malignancies
• Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV)
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
• Baseline blood pressure of \< or equal to 150/100 mmHg. Patients with a blood pressure reading above this level should be initiated on anti-hypertensive therapy and may be considered for protocol treatment when their blood pressure is adequately controlled.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Presence of central nervous system or brain metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study

Sponsors & Collaborators

• University of Arizona: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Chambers SK, Clouser MC, Baker AF, Roe DJ, Cui H, Brewer MA, Hatch KD, Gordon MS, Janicek MF, Isaacs JD, Gordon AN, Nagle RB, Wright HM, Cohen JL, Alberts DS. Overexpression of tumor vascular endothelial growth factor A may portend an increased likelihood of progression in a phase II trial of bevacizumab and erlotinib in resistant ovarian cancer. Clin Cancer Res. 2010 Nov 1;16(21):5320-8. doi: 10.1158/1078-0432.CCR-10-0974.

  PMID: 21041183 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Setsuko K. Chambers, M.D.
• Organization: Arizona Cancer Center, University of Arizona

schambers@azcc.arizona.edu

520-626-0950

Study Officials

• David S Alberts, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: June 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 28, 2012
• Results First Posted: December 14, 2010

Record last verified: 2010-12

Locations

US (1)