A Phase 2 Evaluation of the Monoclonal Antibody, RAV12, in Combination With Standard Gemcitabine in the Treatment of Patients With Metastatic Pancreatic Cancer Who Have Not Been Previously Treated for Metastatic Disease

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Metastatic disease

- No prior therapy for metastatic disease (except prior adjuvant chemotherapy
and/or radiotherapy)

- At least 1 radiographically measurable site of disease ≥ 2 cm in the largest
dimension by traditional CT technique or ≥ 1 cm by spiral CT scan (per RECIST)

- No known history of current or prior central nervous system (CNS) metastatic disease

PATIENT CHARACTERISTICS:

- Eastern Cooperative Oncology Group performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times upper limit of
normal (ULN)

- Alkaline phosphatase and γ-glutamyltransferase ≤ 2.5 times ULN

- Amylase and lipase ≤ 1.5 times ULN

- Total bilirubin ≤ 1.5 times ULN

- Creatinine < 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be available for study-related treatments and assessments at the treating
institution

- No known hypersensitivity to any component of gemcitabine hydrochloride

- No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any
excipient contained in the drug formulation

- No other primary malignancy that has been in remission for ≤ 3 years except treated
nonmelanoma skin cancer, biopsy-confirmed carcinoma in situ of the cervix, squamous
intraepithelial lesion on Papanicolaou smear, localized prostate cancer with Gleason
score < 6, or resected melanoma in situ

- No other primary malignancy that has a generally accepted recurrence risk ≥ 10%

- No active viral, bacterial, or systemic fungal infection requiring parenteral
treatment within 4 weeks of enrollment

- No history of chronic or recurrent infections that require continuous use of
antiviral, antifungal, or antibacterial agents

- No serious underlying medical condition that would impair the patient's ability to
receive or tolerate the planned treatment at the investigational site, including
significant pulmonary compromise or heart disease of New York Heart Association class
III or IV

- No dementia or altered mental status that would preclude sufficient understanding to
provide informed consent

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior major surgery

- More than 4 weeks since prior and no other concurrent investigational agents

- More than 1 week since prior oral antiviral, antifungal, or antibacterial therapy

- No concurrent immunosuppressive medications, steroids (except steroid inhaler,
ophthalmic solution, nasal spray, or a stable dose of ≤ 10 mg/day of oral prednisone
or equivalent), other antineoplastic therapy, or antitumor vaccinations

- Monoclonal antibody treatment for non-cancer indications must be completed at least 3
half lives from study entry

- No concurrent prophylactic hematologic growth factors

- No concurrent megavitamin therapy

- No concurrent bisphosphonates