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Status:

COMPLETED

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

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

Brief 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 ...

Detailed 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 ep...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    28 Patients enrolled

    Trial Details

    Trial ID

    NCT00407758

    Start Date

    November 1 2006

    Last Update

    March 20 2019

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    2

    Rush University Medical Center

    Chicago, Illinois, United States, 60612

    3

    Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, United States, 62526

    4

    Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, United States, 60201-1781