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Phase 2 N=28 Treatment

Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Ovarian Cancer · Primary Peritoneal Cavity Cancer

Enrolled (actual)
28
Serious AEs
44.4%
Results posted
Nov 2017
Primary outcome: Primary: Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 2; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
enzastaurin hydrochloride (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Gynecologic Oncology Group
Primary completion
Aug 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
2; 0
PRIMARY
Progression-free Survival > 6 Months Using RECIST 1.0
3; 24
PRIMARY
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
1; 5; 11; 2; 4; 1
SECONDARY
Duration Overall Survival
15.1
SECONDARY
Duration of Progression-free Survival (PFS)
1.8
SECONDARY
Prognostic Factor - Number of Patients With Platinum Sensitivity
11; 16
SECONDARY
Prognostic Factor - Initial Performance Status
16; 11
SECONDARY
Prognostic Factor - Age at Study Entry
59

Summary

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Recurrent or persistent disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Must have ≥ 1 target lesion to assess response
  • Tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
  • Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
  • Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
  • Must meet any 1 of the following criteria for platinum-based therapy:
  • Disease progression during therapy
  • Treatment-free interval after completion of treatment grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer
  • No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior anticancer hormonal therapy
  • No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease
  • At least 4 weeks since other prior anticancer therapy, including immunotherapy
  • At least 30 days since prior investigational drugs
  • No prior enzastaurin hydrochloride
  • No prior radiotherapy to > 25% of marrow-bearing areas
  • No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease
  • No prior treatment that would preclude treatment on this protocol
  • No concurrent chemotherapy, immunotherapy, or other experimental medications
  • No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin
  • No other concurrent systemic anticancer therapy
  • No concurrent radiotherapy, including palliative radiotherapy
  • No concurrent agents that stimulate thrombopoiesis
  • No concurrent amifostine or other protective reagents
  • Concurrent hormone replacement therapy allowed
  • Concurrent bisphosphonates allowed provided bony metastases are present
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00407758). 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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