A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Inclusion Criteria:

Signed informed consent
Age >= 18 years
Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma
Representative tumor specimens in paraffin blocks or at least 12 unstained slides with an associated pathology report, obtained at any time prior to entry of study for evaluation of HER2 activation
Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded), Or:
Clinically or radiologically detectable disease (e.g., ascites, peritoneal deposits, mesenteric thickening or lesions that do not fulfill RECIST for measurable disease)
Platinum-resistant or refractory carcinoma
Life expectancy >= 12 weeks
ECOG performance status 0 or 1
LVEF >= 50%, as determined by ECHO
Use of an effective means of contraception (for women of childbearing potential)
Clinical laboratory test results: Granulocyte count >= 1500/uL; Platelet count >= 75,000/uL; Hemoglobin >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp(R)] is permitted); Serum bilirubin <= 1.5 the ULN; Alkaline phosphatase, AST, and ALT <= 2.5 ULN (AST, ALT <= 5 ULN for subjects with liver metastasis); Serum creatinine <= 1.5 ULN; International normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (aPTT) <= 1.5 ULN (except for subjects receiving anti-coagulation therapy)

Exclusion Criteria:

Prior treatment with gemcitabine
Two or more prior regimens for the treatment of platinum-resistant disease
Two or more non-platinum-containing regimens for the treatment of platinum-sensitive disease
Prior treatment with experimental anti-cancer agents within 4 weeks prior to Day 1 (the day the first study treatment infusions are administered)
Prior treatment with HER2 pathway inhibitors (e.g., Herceptin(R) [trastuzumab], Iressa(R) [gefitinib], Tarceva [erlotinib hydrochloride], cetuximab, GW572016)
History or clinical evidence of central nervous system or brain metastases
Uncontrolled hypercalcemia ( > 11.5 mg/dL)
Prior exposure of > 360 mg/m^2 doxorubicin or liposomal doxorubicin, > 120 mg/m^2 mitoxantrone, or > 90 mg/m^2 idarubicin
History of other malignancies within 5 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, basal or squamous cell skin cancer
History of serious systemic disease, unstable angina, myocardial infarction within 6 months prior to Day 1 of treatment, symptoms of CHF, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia [i.e., atrial fibrillation, paroxysmal supraventricular tachycardia] are eligible)
Known HIV infection
Pregnancy or lactation
Major surgery or significant traumatic injury within 3 weeks prior to Day 1 of treatment
Inability to comply with study and follow-up procedures
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications