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Cervical Squamous Cell CarcinomaPhase 2NCT00025233

Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Cervical Squamous Cell Carcinoma and Recurrent Cervical Cancer, run by National Cancer Institute (NCI) 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 phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
bevacizumab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Apr 2002to Jul 2009
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 confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix
  • Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
  • Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
  • Documented disease progression
  • At least 1 unidimensionally measurable lesion*
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Show all 59Show fewer
  • No tumor involving major blood vessels
  • No history or physical evidence of CNS disease, including primary or metastatic brain tumor
  • Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population
  • Performance status - GOG 0-2 (if received 1 prior regimen)
  • Performance status - GOG 0-1 (if received 2 prior regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known bleeding disorder or coagulopathy
  • No other active bleeding or pathologic condition that would confer a high risk of bleeding
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • INR ≤ 1.5 (or 2-3 for patients on a stable dose of therapeutic warfarin or low molecular weight heparin)
  • PTT < 1.2 times control
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 60 mL/min
  • No proteinuria
  • Urine protein < 1+ on dipstick or < 30 mg/dL
  • Urine protein < 1000 mg by 24-hour urine collection
  • No clinically significant cardiovascular disease
  • No uncontrolled hypertension
  • No myocardial infarction or unstable angina within the past 6 months
  • No New York Heart Association grade II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No grade II or greater peripheral vascular disease
  • No history of stroke within the past 5 years
  • No greater than grade 1 sensory or motor neuropathy
  • No active infection requiring parenteral antibiotics
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history or physical evidence of seizures not controlled with standard medical therapy
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
  • No significant traumatic injury within the past 4 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
  • No prior bevacizumab
  • At least 3 weeks since prior immunologic agents for SCC of the cervix
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior non-cytotoxic chemotherapy for persistent or recurrent disease
  • At least 1 week since prior hormonal therapy for SCC of the cervix
  • Concurrent hormone replacement therapy allowed
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • Recovered from recent prior surgery
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior placement of vascular access device or core biopsy
  • No concurrent major surgical procedure
  • At least 3 weeks since other prior therapy for SCC of the cervix
  • No prior anticancer therapy that would preclude study therapy
  • No concurrent anticoagulants other than those required to maintain the patency of indwelling IV catheters
  • No concurrent chronic daily aspirin greater than 325 mg/day or other nonsteroidal anti-inflammatory medications that are known to inhibit platelet function at doses used for chronic inflammatory diseases

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Trial of Bevacizumab (rhuMAB VEGF) (NSC #704865) in the Treatment of Persistent and Recurrent Squamous Cell Carcinoma of the Cervix (Group A)

This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Read the detailed description

OBJECTIVES:

  1. Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Estimate the distribution of PFS and overall survival for patients treated with this drug.

IV. Determine the frequency of clinical response (partial and complete) in patients treated with this drug.

  1. Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.

VI. Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38 months.

Being tested
bevacizumab, laboratory biomarker analysis
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00025233
Study groupRoleWhat they receive
Treatment (bevacizumab)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

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

  1. Progression-free Survival Greater Than 6 Months

    Whether or not the patient survived progression-free for at least 6 months.

    Measured: Every other 3-week treatment cycle for 6 months

  2. Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0

    The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.

    Measured: Every cycle and 30 days after the end of treatment. (average 5 months)

Secondary outcomes (5)

  1. Tumor Response

    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

    Measured: Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)

  2. Overall Survival

    The observed length of life from entry into the study to death or the date of last contact.

    Measured: From study entry to death or last contact, up to 5 years.

  3. Duration of Progression-free Survival

    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

    Measured: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years

  4. Performance Status

    Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.

    Measured: Baseline

  5. Age at Enrollment

    Measured: Baseline

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Primary completionJul 2009
  4. Study completionJul 2009

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025233
Sponsor's protocol ID
NCI-2012-02416
Other IDs
NCI-2012-02416, CDR0000068940, GOG-0227C, GOG-0227C, U10CA027469
Status last verified
Jul 2019
First submitted
11 Oct 2001
Last updated
24 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Cervical Squamous Cell Carcinoma and Recurrent Cervical Cancer, run by National Cancer Institute (NCI) 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 59 inclusion and 0 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 24 Jul 2019. 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 29 Jun 2015). 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?

Progression-free Survival Greater Than 6 Months (time frame: Every other 3-week treatment cycle for 6 months). 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 NCT00025233.

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 24 Jul 2019.

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