AzTrials
AzTrials

Ovarian NeoplasmsPhase 2NCT00130520

Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer

A Phase 2 study testing bevacizumab and erlotinib in people with Ovarian Neoplasms, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
bevacizumab and erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jun 2005to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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:
  • Hemoglobin of >10gm/dL,
  • White blood cell count >2500,
  • Platelets >80,000
  • Patients must be ≥ 18 years of age.

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Pregnant (positive pregnancy test) or lactating
  • Urine protein:creatinine ratio > equal to 1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  • Serious, non-healing wound, ulcer, or bone fracture
  • Diagnosis of any other malignancy except non-melanomatous skin cancer in the past 5 years.
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Phase II Open-Label Trial of Erlotinib (Tarceva) and Bevacizumab in Women With Advanced Ovarian Cancer

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).

Read the detailed description

Erlotinib and bevacizumab, novel biologics, offer a new regimen for the treatment of ovarian cancer in women who are refractory to standard drug regimens. Because bevacizumab is an anti-angiogenesis drug and erlotinib is an EGFR receptor inhibitor their combination would lead to the inhibition of multiple signal transduction pathways and the reversal of cancer progression in this difficult to treat population. The study seeks to determine the efficacy and safety of the EGFR receptor inhibitor, erlotinib plus the anti-angiogenesis VEGF ligand inhibitor bevacizumab in women with platinum and taxane refractory ovarian cancer.

The study design is a non-randomized, open label, single center Phase II trial using a Simon two stage design. Eligible patients are women who have a histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease.

Patients will be treated with erlotinib 150 mg/day orally and bevacizumab 10mg/kg every two weeks plus or minus one day intravenously. Forty patients will be enrolled in the study. Initially 20 eligible patients will be accrued. If one or no confirmed response is observed, the trial will be closed and the agents considered inactive. Otherwise, 20 additional eligible patients will be accrued for a total of 40 patients. Eight or more responses out of 40 will be considered evidence warranting further study of the agents provided other factors, such as progression-free and overall survival, also appear favorable.

Previous studies of this combination in non-small cell lung cancer, renal cell carcinoma and metastatic breast cancer have indicated a potential synergistic effect for these two agents. Preliminary data for the use of bevacizumab in advanced ovarian cancer indicates that this agent has single-agent activity. As a result, the researchers are interested in exploring the role of the combination of erlotinib and bevacizumab in advanced ovarian cancer.

Being tested
bevacizumab, erlotinib
Keywords
advanced ovarian cancer, refractory ovarian cancer, primary peritoneal cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    Also called Avastin

    10mg/kg every two weeks IV-bevacizumab

  • erlotinibDrug

    Also called Tarceva

    150mg daily by mouth-erlotinib

Study groups in NCT00130520
Study groupRoleWhat they receive
open labelExperimentalNot described
Receives: Drug: bevacizumab; Drug: erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 06.16.2005 to 10.05.2009

  2. 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)

    Measured: 1 week to 96 weeks

Secondary outcomes (1)

  1. Progression Free Survival(PFS)

    PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause;

    Measured: June 2005 to October 5, 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJan 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130520
Sponsor's protocol ID
HSC #05-47;AVF3117s
Status last verified
Dec 2010
First submitted
12 Aug 2005
Last updated
28 May 2012
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21041183

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and erlotinib in people with Ovarian Neoplasms, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (Complete Partial, Stable and Progression) (time frame: 06.16.2005 to 10.05.2009). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00130520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in