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Phase 2 N=108 Randomized Treatment

Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Recurrent Fallopian Tube Carcinoma · Recurrent Ovarian Carcinoma · Recurrent Primary Peritoneal Carcinoma

Enrolled (actual)
108
Serious AEs
41.0%
Results posted
Oct 2019
Primary outcome: Primary: Progression-free Survival (PFS) — 3.94; 4.39 Months

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Pelareorep (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival (PFS)
3.94; 4.39
PRIMARY
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
3; 17; 0; 1; 5; 15
SECONDARY
Percentage of Participants withTumor Response by RECIST
16.7; 13.0
SECONDARY
Median Overall Survival (OS) by Treatment Group
13.1; 12.6
SECONDARY
Tumor Response by CA125
18.5; 22.2

Summary

This randomized phase II trial studies the side effects and how well giving paclitaxel with or without viral therapy works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral therapy may kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • Patients must have measurable disease or detectable (non-measurable) disease:
  • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography [CT], magnetic resonance imaging [MRI] or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI
  • Detectable (non-measurable) disease is defined as not having measurable disease but has at least one of the following conditions:
  • Baseline values of CA-125 at least 2 x upper limit of normal (ULN);
  • Ascites and/or pleural effusion attributed to tumor;
  • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
  • Patient with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
  • Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
  • Patients who have received two or three prior regimens must have a GOG performance status of 0 or 1
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted and immunologic agents, must be discontinued at least three weeks prior to registration
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents (biologic/targeted) or extended therapy administered after surgical or non-surgical assessment; if patients were treated with paclitaxel for their primary disease, this can have been given weekly or every 3 weeks
  • Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed
  • Patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their treatment for recurrent or persistent disease and/or as treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted) therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will NOT count as a prior regimen
  • For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors will NOT count as a prior regimen when given alone (i.e., not in combination with cytotoxic chemotherapy)

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View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01199263). 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.

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