Phase 2
N=28
Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Ovarian Cancer · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00407758 ↗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
| Outcome | Result | p-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
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.