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Fallopian Tube CancerPhase 2NCT00617773

Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 study testing hu3S193 in people with Fallopian Tube Cancer and Ovarian Cancer, run by Recepta Biopharma at 8 sites in Brazil.

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

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
hu3S193
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
8 sitesBrazil
Study dates
May 2008to Jun 2012
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

  • Karnofsky performance status > 70%
  • Life expectancy ≥ 12 weeks
  • ANC (absolute neutrophil count) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum bilirubin ≤ 2.0 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if with liver metastases)
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  • Creatinine ≤ 2.0 mg/dL
  • Prothrombin time < 1.3 times control
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Who cannot join

  • NYHA (New York Heart Association) class III or IV heart disease
  • Clinically significant arrhythmias by ECG
  • Myocardial infarction within the past 6 months
  • Any other serious illness, including any of the following:
  • Severe ascites
  • Severe active infections requiring antibiotics
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  • Bleeding disorders
  • Chronic inflammatory bowel disease
  • Diseases that might interfere with the collection of accurate results from this study
  • Positive for human anti-human antibodies
  • Prior history of tumor (excluding adequately treated nonmelanoma skin cancer or carcinoma in situ of the uterine cervix)
  • Uncontrolled hypercalcemia (i.e., > 11.5 mg/dL)
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from the toxic effects of any prior therapy
  • No concurrent systemic steroids or immunosuppressant agents
  • No more than 1 prior non-platinum-containing regimen for the treatment of platinum-resistant/refractory disease
  • Patients who receive 2 or more different non-platinum-containing chemotherapy regimens for platinum-resistant/refractory disease are not eligible
  • More than 4 weeks since prior and no other concurrent chemotherapy, radiotherapy, radiopharmaceuticals (e.g., ^32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy, or surgery
  • More than12 weeks since prior investigational agent
  • No prior treatment with a murine or humanized antibody and/or antibody fragment

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Brazil8 sites

  • Hospital da Baleia

    Minas Gerais, 30285-000

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20220-410

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01401-904

  • Hospital das Clinicas FMUSP

    São Paulo, 01246-000

  • Hospital Sirio-Libanes

    São Paulo, 01308-050

  • Hospital Israelita Albert Einstein

    São Paulo, 05651-901

Other trials in Brazil

About this study

Official title: A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria (Response Evaluation Criteria in Solid Tumors).

Secondary

  • To determine the safety of the study drug.
  • To determine the drug pharmacokinetics when administered in multiple weekly injections.

Exploratory analysis

  • Clinical Benefit (objective response rate + tumor stabilization).
  • Progression Free Survival (PFS).
  • Duration of Response.
  • Overall Survival.
  • 12-month survival rate.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu3S193 IV over 1 hour once weekly in weeks 1-8. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly.

Being tested
hu3S193
Keywords
recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • hu3S193Biological

    20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)

Study groups in NCT00617773
Study groupRoleWhat they receive
hu3S193ExperimentalNot described
Receives: Biological: hu3S193

What is being measured

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

  1. Best Overall Response

    Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).

    Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).

Secondary outcomes (4)

  1. Number of Participants With Adverse Events and Serious Adverse Events

    A listing of all adverse events is located in the Reported Adverse Event module.

    Measured: From the first dose of investigational product up to 30 days after the last dose of investigational product

  2. Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).

    Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.

    Measured: From the first dose of investigational product up to 30 days after the last dose of investigational product

  3. Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.

    Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.

    Measured: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.

  4. Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses

    Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.

    Measured: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.

Timeline

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

  1. First posted18 Feb 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2012
  4. Study completionJun 2012

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617773
Sponsor's protocol ID
RCPOv01-06
Other IDs
RCP-Ov-01.06
Status last verified
Nov 2013
First submitted
15 Feb 2008
Last updated
26 Nov 2013
Data monitoring committee
No

Publications

  • Smaletz O, Diz MD, do Carmo CC, Sabbaga J, Cunha-Junior GF, Azevedo SJ, Maluf FC, Barrios CH, Costa RL, Fontana AG, Madrigal V, Wainstein AJ, Yeda FP, Alves VA, Moro AM, Blasbalg R, Scott AM, Hoffman EW. A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Gynecol Oncol. 2015 Aug;138(2):272-7. doi: 10.1016/j.ygyno.2015.05.023. Epub 2015 May 27.

    PubMed 26026738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hu3S193 in people with Fallopian Tube Cancer and Ovarian Cancer, run by Recepta Biopharma at 8 sites in Brazil.

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 11 inclusion and 21 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil. 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 26 Nov 2013). 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?

Best Overall Response (time frame: From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).). 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 NCT00617773, 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 26 Nov 2013.

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