Decitabine and Gemcitabine Hydrochloride in Treating Patients with Metastatic Pancreatic Cancer, Soft Tissue Sarcoma, or Bone Sarcoma

Inclusion Criteria

• Patients must have metastatic histologically or cytologically confirmed pancreatic adenocarcinoma or sarcoma (soft tissue or bone); patient may enroll if he or she refuses first line therapy
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy of greater than 3 months (does not apply to pancreatic cancer population)
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Absolute neutrophil count >= 1,500/mm^3
• Platelets >= 100 k/mm^3
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine =< 1.5 upper limit of normal (ULN)
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) from time of consent and for the duration of study participation as well as for 3 months after the completion of study drug; adequate contraception consists of a double method of contraception, one method of which must be a barrier method; women of child-bearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months); if a woman (or a male subject’s female partner) becomes pregnant or suspects she is pregnant while she is participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Chemotherapy or radiotherapy within 4 weeks (or targeted therapies 5 half-lives) prior to entering the study, or failure to recover from adverse events due to agents administered to =< grade 1 or stable grade 2, at the discretion of the treating physician
• Patients who are receiving any other investigational agents
• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in study
• Prior decitabine for the treatment of this cancer; patients with previous exposure to therapy with gemcitabine are allowed in the study
• Pregnant or breast feeding women are excluded from participating in this study; WOCBP must have a negative serum pregnancy test within 7 days of the first administration of decitabine
• Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements