Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Primary Peritoneal Cavity Cancer
Intervention: enzastaurin hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

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 < 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