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Primary Peritoneal Cavity CancerPhase 2NCT00022659

Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial 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 ovarian epithelial cancer or primary peritoneal cancer. 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
64 participants
Where
1 siteUnited States
Study dates
Apr 2002to Mar 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 confirmed ovarian epithelial or primary peritoneal carcinoma
  • Recurrent or persistent after initial standard surgery or chemotherapy
  • Incurable with standard surgery, chemotherapy, or radiotherapy
  • At least 1 unidimensionally measurable target lesion
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
Show all 69Show fewer
  • Outside the area of prior radiotherapy
  • Accessible to guided core needle biopsy
  • Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
  • May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months
  • Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy
  • No tumors involving major blood vessels
  • No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years
  • Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population)
  • Performance status - GOG 0-2 (patients who have received 1 prior regimen)
  • Performance status - GOG 0-1 (patients who have received 2 prior regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known bleeding disorder or coagulopathy
  • No active bleeding
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • serum glutamate oxaloacetate transaminase (SGOT) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin)
  • Partial thromboplastin time (PTT) < 1.2 times control
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 60 mL/min
  • No proteinuria, as indicated by 1 of the following:
  • Negative urine dipstick
  • Urine protein < 30 mg/dL
  • Urine protein < 1,000 mg on 24-hour urine collection
  • No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension
  • Myocardial infarction within the past 6 months
  • Unstable angina within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2
  • No stroke within the past 5 years
  • No pathologic condition that carries a high risk of bleeding
  • No significant traumatic injury within the past 28 days
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No uncontrolled seizures within the past 5 years
  • No neuropathy (motor and sensory) ≥ grade 2
  • No serious non-healing wound, ulcer, or bone fracture
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No active infection requiring parenteral antibiotics
  • No known claustrophobia that would preclude MRI tolerance
  • No ferromagnetic implants or pacers
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study treatment
  • At least 3 weeks since prior immunologic therapy directed at malignancy
  • No prior bevacizumab
  • No other concurrent immunotherapy directed at malignancy
  • One additional prior cytotoxic regimen for recurrent or persistent disease allowed
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • No concurrent chemotherapy directed at malignancy
  • At least 1 week since prior hormonal therapy directed at malignancy
  • No concurrent hormonal therapy directed at malignancy
  • Concurrent hormone replacement therapy allowed
  • Recovered from prior radiotherapy
  • No concurrent radiotherapy directed at malignancy
  • At least 28 days since prior major surgery or open biopsy and recovered
  • At least 7 days since prior core biopsy or placement of vascular access device
  • No anticipated need for major surgical procedure during study participation
  • At least 3 weeks since other prior therapy directed at malignancy
  • No prior anticancer therapy that would preclude study entry

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 Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. 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

PRIMARY OBJECTIVES:

  1. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.

IV. Determine the frequency of clinical response in patients treated with this drug.

  1. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.

VI. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days 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.

Being tested
bevacizumab, laboratory biomarker analysis
Medical subject headings
Carcinoma, Ovarian Epithelial

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 NCT00022659
Study groupRoleWhat they receive
Treatment (bevacizumab)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days 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 at 6 Months

    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 for 6 months.

  2. 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 for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.

  3. Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.

    Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.

Secondary outcomes (2)

  1. 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.

  2. 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 for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.

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 completionMar 2010
  4. Study completionMar 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022659
Sponsor's protocol ID
NCI-2012-02400
Other IDs
NCI-2012-02400, CDR0000068839, GOG-0170D, GOG-0170D, U10CA027469
Status last verified
Jul 2019
First submitted
10 Aug 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 Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial 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 69 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 12 May 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 at 6 Months (time frame: Every other cycle for 6 months.). The study lists 3 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 NCT00022659.

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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