Phase 2
N=31
Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Fallopian Tube Cancer · Ovarian Cancer · Primary Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00617773 ↗Enrolled (actual)
31
Serious AEs
29.0%
Results posted
Nov 2013
Primary outcome: Primary: Best Overall Response — 0; 0; 13; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- hu3S193 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Recepta Biopharma
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response |
0; 0; 13; 11; 2 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
31; 9 | — |
| SECONDARY Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). |
5; 4; 3; 3; 3; 3 | — |
| SECONDARY Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses. |
16.7; 2.1 | — |
| SECONDARY Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses |
10.9; 2.3 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00617773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.