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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)

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