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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 HospitalBoston, Massachusetts  02114-2617
University of California San FranciscoSan Francisco, California  941104206
Roswell Park Cancer CenterBuffalo, New York  14263
Scripps Health CenterLa Jolla, California  92037
USC Women's and Children's HospitalLos Angeles, California  90033