A Phase II Evaluation of AMG 102 (IND # 107579, NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or persistent ovarian epithelial, fallopian tube,
or primary peritoneal carcinoma

- Histologic confirmation of the original primary tumor via pathology report
required

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper
measurement by clinical exam OR ≥ 20 mm by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis when measured by CT scan or MRI

- Has ≥ 1 "target lesion" to be used to assess response, as defined by RECIST criteria

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days following completion of radiotherapy

- Must have received 1 prior platinum-based chemotherapeutic regimen containing
carboplatin, cisplatin, or another organoplatinum compound for management of primary
disease

- Initial treatment may have included intraperitoneal therapy, high-dose therapy,
consolidation therapy, non-cytotoxic agents, or extended therapy administered
after surgical or non-surgical assessment

- Must have a platinum-free interval of < 12 months, progressed during
platinum-based therapy, or have persistent disease after platinum-based therapy

- One additional cytotoxic regimen for management of recurrent or persistent
disease allowed

- Ineligible for a higher priority GOG protocol, if one exists (e.g., any active GOG
phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

- GOG performance status (PS) 0-2 (for patients who received 1 prior regimen)

- GOG PS 0-1 (for patients who received 2 prior regimens)

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- PTT ≤ 1.5 times ULN

- INR ≤ 1.5 times ULN

- Proteinuria ≤ 1+ by urinalysis OR ≤ 1 g/24 hrs by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No neuropathy (sensory or motor) > grade 1

- No peripheral edema or lymphedema > grade 2

- No active bleeding diathesis

- No thromboembolic or ischemic event within the past 12 months, including any of the
following:

- Deep venous thrombosis

- Pulmonary embolism

- Transient ischemic attack

- Cerebral infarction

- Myocardial infarction

- No serious or non-healing wound

- No known HIV or hepatitis C positivity or chronic or active hepatitis B

- No active infection requiring antibiotics

- Uncomplicated urinary tract infection allowed

- No other concurrent serious infection or nonmalignant medical illness that is
uncontrolled or whose control may be jeopardized by study treatment

- No psychiatric condition or other condition that would preclude giving informed
consent or meeting study requirements

- No history of primary endometrial cancer unless all of the following criteria are
met:

- No greater than stage IB disease

- No more than superficial myometrial invasion

- No vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serious, clear cell, or
other FIGO grade 3 lesions

- No other invasive malignancies within the past 3 years except for nonmelanoma skin
cancer or localized cancer of the breast, head and neck, or skin

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior surgery, radiotherapy, or chemotherapy

- No prior cancer treatment that would contraindicate study treatment

- No prior fully human anti-HGF monoclonal antibody AMG 102 or other HGF/c-met pathway
inhibitors

- No prior non-cytotoxic therapy for management of recurrent or persistent disease

- Prior biologic (non-cytotoxic) therapy as part of primary treatment regimen
allowed

- No prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for
the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the
past 3 years

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
allowed provided it was completed > 3 years ago and the patient remains free of
recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment
of ovarian, fallopian tube, or primary peritoneal cancer within the past 3 years

- Prior adjuvant chemotherapy for localized breast cancer allowed provided it was
completed > 3 years ago and the patient remains free of recurrent or metastatic
disease

- More than 30 days since prior surgery (14 days for minor surgical procedures)

- Central venous catheter placement allowed at any time point before study
enrollment provided the patient has recovered and any surgical wound has healed

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- At least 3 weeks since any other prior therapy directed at the malignant tumor,
including immunologic agents

- More than 7 days since prior and no concurrent therapeutic anti-coagulation therapy
with warfarin, heparin, or low molecular weight heparin

- Low-dose warfarin (≤ 2 mg orally daily) for prophylaxis against central venous
catheter thrombosis allowed