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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:

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.


Sponsor: Recepta Biopharma

Current Primary Outcome: 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). ]

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.



Original Primary Outcome:

  • Tumor response as measured by RECIST criteria
  • Response as measured by CA-125 decline


Current Secondary Outcome:

  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: From the first dose of investigational product up to 30 days after the last dose of investigational product ]
    A listing of all adverse events is located in the Reported Adverse Event module.
  • Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). [ Time Frame: From the first dose of investigational product up to 30 days after the last dose of investigational product ]
    Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.
  • Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses. [ Time Frame: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1. ]
    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.
  • Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses [ Time Frame: 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. ]
    Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.


Original Secondary Outcome:

  • Treatment safety during and for up to 30 days after completion of study treatment
  • Pharmacokinetics
  • Clinical benefit (objective response rate plus tumor stabilization)
  • Progression-free survival
  • Duration of response
  • Overall survival
  • Survival rate at 12 months


Information By: Recepta Biopharma

Dates:
Date Received: February 15, 2008
Date Started: May 2008
Date Completion:
Last Updated: November 1, 2013
Last Verified: November 2013