Overview

This trial is active, not recruiting.

Conditions ovarian cancer, primary peritoneal cavity cancer
Treatment enzastaurin hydrochloride
Phase phase 2
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date November 2006
End date January 2013
Trial size 68 participants
Trial identifier NCT00407758, CDR0000517318, GOG-0170J, LILLY-H6Q-MC-S025

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response
time frame:
Frequency and severity of adverse effects as measured by CTCAE v3.0
time frame:

Secondary Outcomes

Measure
Duration of PFS and overall survival
time frame:
Prognostic factors, including platinum sensitivity, initial performance status, and age
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).