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Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Peritoneal Neoplasms

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Trial Information

Inclusion Criteria:

- Must give written informed consent and any authorizations required by local law
(e.g., Protected Health Information [PHI]).

- Females aged ≥18 years old at the time of informed consent.

- Advanced (Stage III or IV), histologically-documented epithelial ovarian cancer or
primary peritoneal cancer (excluding small, round-cell histologies).

- Radiologically-documented evidence of progressive disease.

- Platinum-resistant disease defined as having a best response of SD or disease
progression during or within 6 months of discontinuing a platinum-based chemotherapy
(carboplatinum, cisplatinum, or another organoplatinum compound).

- Progression during or following treatment with topotecan or liposomal doxorubicin.

- Three or fewer prior chemotherapy regimens (including a platinum-based therapy).

- At least 1 measurable target lesion in accordance with RECIST criteria to assess
clinical response (tumors within a previously irradiated field are designated as

- ECOG Performance Status ≤1.

- Life expectancy >12 weeks.

- Available paraffin block or unstained paraffin sections on glass slides containing
representative tumor tissue from the most recent tumor biopsy/resection.

- Subjects of child-bearing potential must be willing to practice effective
contraception during the study and be willing and able to continue contraception for
at least 6 months after their last dose of study treatment (about 5 half lives).

Exclusion Criteria:

- Screening clinical laboratory values:

- Absolute neutrophil count <1500/µL

- Platelet count <75,000/µL

- Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion,
erythropoietin, or other approved hematopoietic growth factors; darbopoeitin
[Aranesp®] is permitted)

- Serum bilirubin >2.0 x upper limit of normal (ULN)

- AST and ALT >2.5 x ULN (AST and ALT >5 × ULN for subjects with liver metastasis)

- Serum creatinine >2.0 mg/dL

- International normalized ratio (INR) >1.5

- Activated partial thromboplastin time (aPTT) >1.5 × ULN

- Clinically significant peripheral vascular disease.

- Non-epithelial ovarian tumors.

- Active infection requiring systemic antibiotics, antivirals, or antifungals including
HIV/AIDS, hepatitis B, or hepatitis C infection.

- History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal
abscess within 6 months prior to Day 1.

- Serious, non-healing wound, or bone fracture.

- Known central nervous system or brain metastases.

- History of uncontrolled psychiatric condition within 6 months prior to Day 1.

- History of other malignancies within 3 years of Day 1, except for adequately treated
carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal
or squamous cell skin cancer.

- Evidence of autoimmune disease including, but not limited to, ulcerative colitis,
Crohn's disease, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)
sceloderma, or another diseases in which immune function or immune competence is
known to be impaired.

- Any history of lymphoproliferative disorder.

- Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA).

- Any medical condition that may be exacerbated by bleeding, including a known bleeding
disorder such as a coagulation defect, thrombocytopenia, active gastric or duodenal
ulcer, or history of GI bleeding.

- Significant hemoptysis within one year prior to Study Day 1.

- Any investigational, anti-cancer therapy within 6 weeks prior to Day 1.

- Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1.

- Prior treatment with anti-angiogenic agents.

- Subjects who require treatment with an anti-coagulant with the exception of low-dose
Aspirin® (≤81 mg/day), warfarin (≤1 mg/day), or heparin for IV catheter patency.

- Subjects who are taking concomitant immunomodulatory agents including, but not
limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus,
calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of
inhaled or intranasal steroids or oral steroids at a dose of ≤10 mg/day prednisone or
its equivalent are permitted.)

- Active, unstable severe cardiovascular disease, including poorly controlled angina,
congestive heart failure (CHF), arrhythmias, myocardial infarction (MI),
cardiomyopathy, atrioventricular (AV) block, electrocardiogram (ECG) evidence of
acute ischemia, or significant conduction abnormality.

- History of thromboembolic or cerebrovascular events, such as stroke, or transient
ischemic attack (TIA). (Note: Prior history of deep vein thrombosis will not exclude
subjects from participating in this study.)

- Pregnant (positive pregnancy test) or lactating.

- Inability to comply with study and follow-up procedures.

- Any condition that, in the opinion of the Investigator, makes the subject unsuitable
for study participation.

- Known hypersensitivity to murine or chimeric antibodies.

- Major surgery within 4 weeks prior to Day 1.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria.

Outcome Time Frame:

Baseline, and every 8 weeks on study

Safety Issue:


Principal Investigator

Carolyn Matthews, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Medical Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

April 2008

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Neoplasms
  • epithelial ovarian cancer
  • peritoneal cancer
  • platinum-resistant ovarian cancer
  • Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



Memorial Sloan Kettering Cancer Center New York, New York  10021
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
James Graham Brown Cancer Center Louisville, Kentucky  40202
Florida Hospital Cancer Institute Orlando, Florida  32804
Montefiore Medical Center Bronx, New York  10467-2490
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Mary Crowley Medical Research Center Dallas, Texas  75246
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Chicago Chicago, Illinois  60637
UCI Medical Center Irvine, California  92868
Sharp Hospital San Diego, California  92123
Indiana University Indianapolis, Indiana  46202
Memorial Health University Medical Center Savannah, Georgia  31404
UCLA JCCC Clinical Research Unit Los Angeles, California  90024
Johns Hopkins Kimmel Cancer Center Baltimore, Maryland  21231-1000
Billings Clinic (MCMRC network) Billings, Montana  59101
Oklahoma University Health Science Center Oklahoma City, Oklahoma  73104
Texas Oncology PA, Presbyterian Dallas, Texas  75231