Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer
This trial is active, not recruiting.
|Conditions||ovarian cancer, neoplasms, carcinoma|
|Sponsor||Eli Lilly and Company|
|Collaborator||Gynecologic Oncology Group|
|Start date||January 2007|
|End date||May 2008|
|Trial size||50 participants|
|Trial identifier||NCT00420381, 10738, H6Q-MC-S025|
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in patients with recurrent or persistent ovarian cancer.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Frequency of patients who survive progression-free for at least 6 months or have objective tumor response
time frame: 6 months
Frequency and severity of adverse effects
time frame: every cycle
Duration of progression-free survival and overall survival
time frame: baseline to measured progressive disease or date of death from any cause
Prognostic factors such as platinum sensitivity, initial performance status, and age
time frame: baseline
Female participants at least 18 years old.
- Patients must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
- All patients must have measurable disease.
- Patients must have at least one "target lesion" to be used to assess response on this protocol.
- Patients must not be eligible for a higher priority GOG protocol, if one exists.
- Patients who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Patients who have received two prior regimens must have a GOG Performance Status of 0 or 1.
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
- Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
- Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.
- Patients with previous enzastaurin treatment.
- Patients who have received radiation to more than 25% of marrow-bearing areas
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Patients who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
- Patients who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
- Patients who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
- Patients with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
|Official title||A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma|
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