The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.

Condition	Treatment or Intervention	Phase
Ovarian Neoplasms	Drug: intravenous T900607-sodium	Phase II

Further Study Details: 

Expected Total Enrollment:  35

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of ovarian cancer
• Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel)
• 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

California
      USC Women's and Children's Hospital, Los Angeles,  California,  90033,  United States
      Scripps Health Center, La Jolla,  California,  92037,  United States
      University of California San Francisco, San Francisco,  California,  94115,  United States
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
New York
      Roswell Park Cancer Center, Buffalo,  New York,  14263,  United States

Study chairs or principal investigators

Kerrie Boyd,  Study Chair,  Tularik   

Study ID Numbers:  T-607-005
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  August 8, 2002
ClinicalTrials.gov Identifier:  NCT00043446
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08