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Investigator(s):
Elise C. Kohn, M.D. Principal Investigator Phone: 301-402-2726 kohne@mail.nih.gov	Christina M. Annunziata, M.D., Ph.D. Protocol Chair Phone: 301-402-7189 Fax: 301-480-6255 annunzic@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Nicole Houston, B.S.N., R.N. Research Nurse Phone: 301-443-6431 houstonnd@mail.nih.gov

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Primary Eligibility:

• Dose escalation cohort:
• Histological confirmation of any of the following cancer types: ovarian, fallopian tube, primary peritoneal, endometrial, cervical, breast, prostate, non-small cell lung, colon, esophageal, gastric, bladder, renal cell carcinoma, or melanoma
• Relapsed or refractory to ≥ 1 prior standard care systemic regimen
• Subjects with relapsed or refractory breast, epithelial ovarian, or colon cancer must have progressed through > 1 prior regimen of therapy
• Measurable disease desirable but not required
• Dose expansion cohort:
• Relapsed or refractory epithelial ovarian cancer with progression through > 1 prior regimen of therapy, or relapsed or refractory fallopian tube cancer, or primary peritoneal cancer with progression after ≥ 1 prior standard care systemic regimen
• Relapsed or refractory ovarian cancer with an archival tumor sample that demonstrates EphA2 expression by immunohistochemical stain
• Measurable disease required
• No history of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, or superficial bladder cancer
• ≥ 18 years of age
• ECOG 0–2
• Recovered from prior therapy and at least 4 weeks from prior treatment
• ANC ≥ 1,500/mm³
• Platelets ≥ 100,000/mm³
• Hemoglobin > 10 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance > 50 mL/min
• Serum bilirubin ≤ 2 x ULN
• Alkaline phosphatase < 3 x ULN
• AST and ALT ≤ 3 x ULN
• Prothrombin time (PT), partial thormboplastin time (PTT), and international normalized ratio (INR) within normal limits
• No history of central nervous system metastases or primary central nervous system tumors
• No evidence of prior bleeding events (e.g., hematemesis, melena, hematochezia, hemoptysis or hematuria)
• No active or recent history (within 3 months) of keratitis or conjunctivitis
• No history of significant adverse events related to a previously administered monoclonal antibody
• No medical condition that would preclude study participation
• No history of HIV or hepatitis virus infection
• No history of myocardial infarction, angina, or arrhythmia within 6 months prior to beginning MEDI-547
• No marked prolongation of QTc interval (≥ 500 ms on EKG)
• No uncontrolled hypertension (BP >150/100) within 3 months prior to beginning MEDI-547
• No evidence of severe congestive heart failure with NYHA classification > Class1 within 3 months prior to beginning MEDI-547
• No prior TIA or stroke within 6 months prior to beginning MEDI-547
• No anticoagulant therapy for thromboembolic disorders or prophylactic reasons
• Not pregnant or nursing; must agree to practice an effective method of contraception beginning when the informed consent form is signed, and must agree to continue using such precautions while receiving MEDI-547 through 30 days after the last dose of MEDI-547

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Study Outline:

This is a Phase I, open-label study in subjects with solid tumors relapsed or refractory to standard therapy.

Dose escalation cohort:

• MEDI-547 will be administered according to two schedules: q3Week or qWeek
• Initially, subjects will enroll into the q3Week administration schedule at NIH
• Cohorts will enroll into the qWeek schedule at MD Anderson once the dose level in the q3Wk safely reaches 3 x the starting dose, in order to achieve equivalent cumulative dose per cycle

Dose expansion cohort:

• Patients with relapsed or refractory ovarian, fallopian tube, or primary peritoneal cancer whose tumor samples demonstrate EphA2 expression

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.

Reviewed: 9/3/09
Updated: 7/24/09