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Phase 2
18 Years
Open (Enrolling)
Ovarian Neoplasms

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Trial Information

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of ovarian cancer

- Subjects must have received 1-2 regimens of prior chemotherapy (with one containing

- At least 18 years of age

- Bidimensionally measurable disease amenable to CT scanning. At least one lesion must
be least 1 X 1 cm in size.

- Karnofsky performance status of at least 70%

- Estimated life expectancy of at least 12 weeks

- Females of childbearing potential must have a negative pregnancy test and agree to
use an effective contraceptive

- Subject must be able to comply with study procedures and follow-up examinations.

- Signed written informed consent

- Lab Values (obtained ≤ 7 days prior to study enrollment):

- ANC at least 1.5x10e9/L,

- Platelet count at least 100x10e9/L,

- Hemoglobin at least 8.5 g/dL,

- Creatinine within 2 times upper limit of normal

- AST and ALT within 3 times upper limit of normal

- Bilirubin within 1.5 times upper limit of normal

- Albumin great than 2.5 g/dL

- INR < 1.5 for subjects without anticoagulants

Exclusion Criteria

- Severe, concurrent disease, infection or co-morbidity that, in the judgment of the
investigator, would make the subject inappropriate for enrollment

- NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%,
or acute anginal symptoms

- Patients who have received any investigational agent within 4 weeks of enrollment

- Patients who are pregnant or breast-feeding

- History of prior malignancy other than ovarian cancer within the last 5 years, except
for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
of the cervix

- History of central nervous system metastases or carcinomatous meningitis

- Major surgery within 4 weeks of enrollment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kerrie Boyd

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of California San Francisco San Francisco, California  941104206
Roswell Park Cancer Center Buffalo, New York  14263
Scripps Health Center La Jolla, California  92037
USC Women's and Children's Hospital Los Angeles, California  90033