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Cervical CancerPhase 2NCT00545792

Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers

A Phase 2 study testing Avastin in people with Cervical Cancer and Endometrial Cancer, run by Dana-Farber Cancer Institute 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
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Trial summary

This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Avastin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
May 2007to Oct 2013
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

  • All patients (age > 18 years) will have locally recurrent gynecological cancer with a component of disease that will fit within a standard RT portal at the time of presentation
  • ECOG performance status score 0-1
  • All patients will have had a prior hysterectomy
  • Histological confirmation of recurrent gynecological cancer, including adenocarcinoma, papillary serous carcinoma, clear cell carcinoma, or carcinosarcoma
  • Age > 18 years
  • Radiologic work-up computer tomography of the chest and abdomen, and computer tomography or MR of the pelvis confirming pelvis-confined recurrence
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  • Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
  • Adequate hepatic function as evidenced by:
  • Serum total bilirubin < 1.5 mg/dL SGOT/SGPT < 3X the ULN for the reference lab
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients with a prior history of full course external beam radiation therapy to the pelvis (patients with prior vaginal brachytherapy may be included)
  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 12 weeks
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored avastin cancer study
  • Known CNS disease (including history of encephalitis, multiple sclerosis or seizure disorder), except for treated brain metastasis
  • Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
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  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Known CNS disease (including history of encephalitis, multiple sclerosis or seizure disorder)
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Any surgical procedure requiring an incision, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for any surgical procedure requiring an incision during the course of the study (excluding vascular access device placement or procedures that do not require an incision)
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture
  • Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • Known hypersensitivity to any component of avastin
  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or to interfere with the investigator's ability to interpret the results

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Pilot Study Evaluating The Safety Of Avastin And Pelvic Radiation In Women With Pelvic-Confined Recurrence of Gynecological Cancers

This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).

Read the detailed description

The purpose of this research study is to learn the effects (good and bad) of an antiangiogenic therapy drug (drugs that stop new blood vessel growth and starve a tumor by cutting off its blood supply) called avastin. Avastin is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a well-defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In laboratory studies, avastin has been shown to inhibit the growth of several different types of human cancer cells.

This drug has been studied in at least 3500 people with breast, colorectal, renal, ovarian and lung cancer. It has not been studied in combination radiation therapy in people with recurrent gynecological cancer.

Previous clinical trials involving the use of avastin in combination with standard radiation in colorectal and pancreatic cancer show no significant increase in toxicity as compared to standard radiation therapy toxicity.

The primary objective of this study is to assess the toxicity of administering avastin with radiation for recurrent gynecological cancer. The secondary endpoint will be to assess the time to progression of the disease. This means we hope this treatment program will delay any regrowth of your cancer as compared to standard therapy with radiotherapy alone. In addition, how well you respond to the treatment, patterns of remission or recurrence will be measured.

Being tested
Avastin
Keywords
Recurrent Endometrial cancer, Recurrent Cervical cancer, Recurrent Ovarian cancer, Recurrent Vaginal cancer, Recurrent Vulvar cancer, Vaginal recurrence, Brachytherapy, Radiation Treatment, External Beam Radiation, Avastin, Bevacizumab
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms

What participants receive

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

  • AvastinDrug

    Also called Bevacizumab

    Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.

Study groups in NCT00545792
Study groupRoleWhat they receive
AvastinExperimentalAvastin
Receives: Drug: Avastin

What is being measured

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

  1. Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

    Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.

    Measured: 1-year

Secondary outcomes (1)

  1. Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

    Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.

    Measured: 1-year

Timeline

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

  1. First posted17 Oct 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionNov 2010
  4. Study completionOct 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00545792
Sponsor's protocol ID
07-042
Other IDs
AVF3998s
Status last verified
Feb 2017
First submitted
15 Oct 2007
Last updated
15 Mar 2017
Data monitoring committee
Yes

Publications

  • Viswanathan AN, Lee H, Berkowitz R, Berlin S, Campos S, Feltmate C, Horowitz N, Muto M, Sadow CA, Matulonis U. A prospective feasibility study of radiation and concurrent bevacizumab for recurrent endometrial cancer. Gynecol Oncol. 2014 Jan;132(1):55-60. doi: 10.1016/j.ygyno.2013.10.031. Epub 2013 Nov 4.

    PubMed 24201015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin in people with Cervical Cancer and Endometrial Cancer, run by Dana-Farber Cancer Institute 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 10 inclusion and 20 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 15 Mar 2017. 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 2 Jul 2014). 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?

Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy (time frame: 1-year). 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 NCT00545792, 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 15 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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