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

Brief Title

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

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

Brief 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.

      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.

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Best Overall Response

Secondary Outcome

 Number of Participants With Adverse Events and Serious Adverse Events

Condition

Fallopian Tube Cancer

Intervention

hu3S193

Study Arms / Comparison Groups

 hu3S193

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

May 2008

Completion Date

June 2012

Primary Completion Date

June 2012

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
             carcinoma

               -  Progressive disease

               -  Disease must express Lewis-Y antigen documented by immunohistochemistry in
                  archived or fresh primary or metastatic tumor biopsies

          -  Measurable disease, including at least one measurable lesion, according to RECIST
             criteria or CA-125 (Cancer Antigen-125) > 2 times upper normal limit

               -  Pleural effusion, ascites, bone metastases, and lesions located in previously
                  irradiated areas are not considered measurable

          -  Disease must be considered platinum-refractory or resistant, meeting any of the
             following criteria:

               -  Platinum-refractory defined as progression during the initial platinum-based
                  chemotherapy regimen or failure to achieve a complete response (e.g., stable
                  disease or partial response) with evidence of progressive disease (by physical
                  examination, radiological exams, or CA-125) during the initial platinum-based
                  chemotherapy

               -  Platinum-resistant defined as recurrence within six months of completion of the
                  initial platinum-based regimen (primary platinum-resistance) or recurrence after
                  six months of completion of the initial platinum-based regimen (still considered
                  platinum-sensitive, but incurable by any approach, that will progress to a
                  secondary platinum-resistance scenario) and failure to ≥ 1 re-induction with a
                  platinum-based regimen (secondary platinum-resistance)

          -  No high tumor burden, as assessed by the investigator

          -  No rapidly progressing disease, as assessed by clinical evaluation

          -  No known CNS (Central Nervous System) involvement by tumor

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  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)

          -  Creatinine ≤ 2.0 mg/dL

          -  Prothrombin time < 1.3 times control

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  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

               -  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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Oren Smaletz, MD, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT00617773

Organization ID

RCPOv01-06

Secondary IDs

RCP-Ov-01.06

Responsible Party

Sponsor

Study Sponsor

Recepta Biopharma

Study Sponsor

Oren Smaletz, MD, Study Chair, Recepta Biopharma

Verification Date

November 2013