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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response

Safety Issue:

No

Principal Investigator

Lydia Usha, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000517318

NCT ID:

NCT00407758

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052