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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer

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Trial Information

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


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.

Secondary

- To determine the safety of the study drug.

- To determine the drug pharmacokinetics when administered in multiple weekly injections.

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.

Inclusion 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 > 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 involvement by tumor

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Karnofsky performance status > 70%

- Life expectancy ≥ 12 weeks

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Serum bilirubin ≤ 2.0 mg/dL

- AST and ALT ≤ 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 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

RECIST criteria or CA-125 level

Outcome Time Frame:

baseline and every 8 weeks up to 24 weeks

Safety Issue:

No

Principal Investigator

Oren Smaletz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Recepta Biopharma

Authority:

United States: Food and Drug Administration

Study ID:

RCPOv01-06

NCT ID:

NCT00617773

Start Date:

May 2008

Completion Date:

June 2012

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

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