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Ovarian CancerPhase 2NCT00516841

A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

A Phase 2 study testing Volociximab in people with Ovarian Cancer and Peritoneal Neoplasms, run by Facet Biotech at 23 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Peritoneal Neoplasms
What is being tested?
Volociximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
23 sitesin 2 countries
Study dates
Aug 2007to Apr 2008
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
  • Females aged ≥18 years old at the time of informed consent.
  • Advanced (Stage III or IV), histologically-documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
  • Radiologically-documented evidence of progressive disease.
  • Platinum-resistant disease defined as having a best response of SD or disease progression during or within 6 months of discontinuing a platinum-based chemotherapy (carboplatinum, cisplatinum, or another organoplatinum compound).
  • Progression during or following treatment with topotecan or liposomal doxorubicin.
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  • Three or fewer prior chemotherapy regimens (including a platinum-based therapy).
  • At least 1 measurable target lesion in accordance with RECIST criteria to assess clinical response (tumors within a previously irradiated field are designated as non-target).
  • ECOG Performance Status ≤1.
  • Life expectancy >12 weeks.
  • Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection.
  • Subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment (about 5 half lives).

Who cannot join

  • Screening clinical laboratory values:
  • Absolute neutrophil count <1500/µL
  • Platelet count <75,000/µL
  • Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion, erythropoietin, or other approved hematopoietic growth factors; darbopoeitin [Aranesp®] is permitted)
  • Serum bilirubin >2.0 x upper limit of normal (ULN)
  • AST and ALT >2.5 x ULN (AST and ALT >5 × ULN for subjects with liver metastasis)
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  • Serum creatinine >2.0 mg/dL
  • International normalized ratio (INR) >1.5
  • Activated partial thromboplastin time (aPTT) >1.5 × ULN
  • Clinically significant peripheral vascular disease.
  • Non-epithelial ovarian tumors.
  • Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
  • History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1.
  • Serious, non-healing wound, or bone fracture.
  • Known central nervous system or brain metastases.
  • History of uncontrolled psychiatric condition within 6 months prior to Day 1.
  • History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer.
  • Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) sceloderma, or another diseases in which immune function or immune competence is known to be impaired.
  • Any history of lymphoproliferative disorder.
  • Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA).
  • Any medical condition that may be exacerbated by bleeding, including a known bleeding disorder such as a coagulation defect, thrombocytopenia, active gastric or duodenal ulcer, or history of GI bleeding.
  • Significant hemoptysis within one year prior to Study Day 1.
  • Any investigational, anti-cancer therapy within 6 weeks prior to Day 1.
  • Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1.
  • Prior treatment with anti-angiogenic agents.
  • Subjects who require treatment with an anti-coagulant with the exception of low-dose Aspirin® (≤81 mg/day), warfarin (≤1 mg/day), or heparin for IV catheter patency.
  • Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of ≤10 mg/day prednisone or its equivalent are permitted.)
  • Active, unstable severe cardiovascular disease, including poorly controlled angina, congestive heart failure (CHF), arrhythmias, myocardial infarction (MI), cardiomyopathy, atrioventricular (AV) block, electrocardiogram (ECG) evidence of acute ischemia, or significant conduction abnormality.
  • History of thromboembolic or cerebrovascular events, such as stroke, or transient ischemic attack (TIA). (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.)
  • Pregnant (positive pregnancy test) or lactating.
  • Inability to comply with study and follow-up procedures.
  • Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
  • Known hypersensitivity to murine or chimeric antibodies.
  • Major surgery within 4 weeks prior to Day 1.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States19 sites

  • Johns Hopkins Kimmel Cancer Center

    Baltimore, Maryland, 21231-1000

  • Billings Clinic (MCMRC network)

    Billings, Montana, 59101

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of Chicago

    Chicago, Illinois, 60637

  • Texas Oncology PA, Presbyterian

    Dallas, Texas, 75231

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Indiana University

    Indianapolis, Indiana, 46202

  • UCLA JCCC Clinical Research Unit

    Los Angeles, California, 90024

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Oklahoma University Health Science Center

    Oklahoma City, Oklahoma, 73104

  • UCI Medical Center

    Orange, California, 92868-3201

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Sharp Hospital

    San Diego, California, 92123

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

Canada4 sites

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G1Z2

  • London Health Sciences Center

    London, Ontario, NGA4L6

  • McGill University Hospital

    Montreal, Quebec, H3A 1A1

Other trials in Canada

About this study

To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.

Being tested
Volociximab
Keywords
epithelial ovarian cancer, peritoneal cancer, platinum-resistant ovarian cancer, Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer
Medical subject headings
Ovarian Neoplasms, Peritoneal Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • VolociximabDrug

    Also called M200

    15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops

Study groups in NCT00516841
Study groupRoleWhat they receive
volociximabExperimental15 mg/kg volociximab once weekly
Receives: Drug: Volociximab

What is being measured

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

  1. Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria.

    Measured: Baseline, and every 8 weeks on study

Timeline

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

  1. First posted16 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Why it stopped: Decision to terminate recruitment based on lack of efficacy

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00516841
Sponsor's protocol ID
206OC201
Status last verified
Aug 2012
First submitted
14 Aug 2007
Last updated
23 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Volociximab in people with Ovarian Cancer and Peritoneal Neoplasms, run by Facet Biotech at 23 sites in 2 countries.

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 12 inclusion and 34 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: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada. 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?

The study was stopped early (reason given: Decision to terminate recruitment based on lack of efficacy). Results are not available in the source record.

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?

Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria. (time frame: Baseline, and every 8 weeks on study). 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 NCT00516841.

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 23 Aug 2012.

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