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Primary Peritoneal CarcinomaPhase 2NCT00072566

Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

A Phase 2 study testing Bevacizumab, Cyclophosphamide and Laboratory Biomarker Analysis in people with Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, 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 combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Bevacizumab, Cyclophosphamide and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
Dec 2003to Nov 2008
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
  • Unidimensionally measurable disease
  • Previously irradiated indicator lesions must have progressed after radiotherapy
  • Received a platinum-containing regimen for primary disease
  • No more than 2 prior chemotherapy regimens for recurrent disease
  • Must have received prior platinum-based chemotherapy for recurrent disease if it has been > 12 months since treatment for primary disease (except if hypersensitivity to platinum has developed)
Show all 56Show fewer
  • Rechallenge with the same platinum-based regimen is considered 1 prior regimen
  • No history or clinical evidence of CNS disease, including primary brain tumor
  • No brain metastases
  • Performance status - SWOG 0-2
  • At least 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No bleeding diathesis
  • No coagulopathy
  • Bilirubin no greater than 1.5 times normal
  • ALT or AST no greater than 3 times upper limit of normal
  • INR less than 1.5 (for patients receiving warfarin)
  • Creatinine no greater than 1.5 times normal
  • No proteinuria (less than 1+)
  • Proteinuria less than 500 mg/24-hour urine collection
  • No prior deep vein thrombosis
  • No prior stroke
  • No clinically significant cardiovascular disease
  • None of the following within the past year:
  • Uncontrolled hypertension
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Grade II or greater peripheral vascular disease
  • None of the following within the past 6 months:
  • Unstable angina
  • Myocardial infarction
  • Transient ischemic attack
  • Cerebrovascular accident
  • Other arterial thromboembolic event
  • No clinically significant peripheral artery disease
  • No active infection requiring parenteral antibiotics
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No serious, non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No seizures not controlled with standard medical therapy
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • All prior invasive malignancies must be in complete remission
  • No other concurrent medical, psychological, or social condition that would preclude study participation
  • No prior antiangiogenesis agents
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • More than 28 days since prior major surgical procedure or open biopsy and recovered
  • At least 3 weeks since prior therapy directed at the malignancy
  • No recent or concurrent full-dose anticoagulants or thrombolytic agents
  • Anticoagulants to maintain patency of preexisting, permanent indwelling IV catheters allowed
  • No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide may kill more tumor cells.

Read the detailed description

OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide.

Secondary I. Determine the response rate in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Determine molecular correlates for response and outcomes in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2 years.

Being tested
Bevacizumab, Cyclophosphamide, Laboratory Biomarker Analysis
Medical subject headings
Ovarian 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, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00072566
Study groupRoleWhat they receive
Treatment (bevacizumab, cyclophosphamide)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Median Time to Progression

    Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Response Rate Based on the RECIST

    Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.

    Measured: Up to 3 years

  2. Median Overall Survival

    Calculated using the method of Kaplan-Meier.

    Measured: Time from first day of treatment to time of death due to any cause, assessed up to 3 years

Timeline

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

  1. First posted5 Nov 2003 (estimated)
  2. Study startDec 2003
  3. Primary completionNov 2008
  4. Study completionNov 2008

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072566
Sponsor's protocol ID
NCI-2012-02562
Other IDs
NCI-2012-02562, NCI-5789, CHNMC-PHII-45, CDR0000340522, CCC-PHII-45, PHII-45, 5789, N01CM17101
Status last verified
Dec 2012
First submitted
4 Nov 2003
Last updated
12 May 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Cyclophosphamide and Laboratory Biomarker Analysis in people with Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, 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 56 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 12 May 2015. 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?

Median Time to Progression (time frame: Up to 3 years). 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 NCT00072566.

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 12 May 2015.

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