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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00407758 |
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Date of registration:
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04/12/2006 |
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Primary sponsor: |
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Public title:
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Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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Scientific title:
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A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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68 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00407758 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jean A. Hurteau, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NorthShore University HealthSystem Research Institute |
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Name:
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Lydia Usha, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush University Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Primary Peritoneal Cavity Cancer
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Intervention(s)
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Drug: enzastaurin hydrochloride
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Primary Outcome(s)
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Frequency and severity of adverse effects as measured by CTCAE v3.0
[Time Frame: Yes]
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Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response
[Time Frame: No]
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Secondary Outcome(s)
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Duration of PFS and overall survival
[Time Frame: No]
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Prognostic factors, including platinum sensitivity, initial performance status, and age
[Time Frame: No]
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Secondary ID(s)
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CDR0000517318
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GOG-0170J
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LILLY-H6Q-MC-S025
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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