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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Ovarian Cancer

Treatments

Drug: enzastaurin hydrochloride

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00407758

LILLY-H6Q-MC-S025

CDR0000517318

GOG-0170J

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

Determine the duration of progression-free and overall survival of patients treated with this regimen.
Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Enrollment

28 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 < 12 months
  - Disease persistence after completion of therapy
Ineligible for a higher priority GOG clinical trial

PATIENT CHARACTERISTICS:

GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL (transfusions allowed)
Creatinine < 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 2 times ULN
Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Able to swallow tablets
No sensory or motor neuropathy > 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