Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma

The objectives of this study are to assess the safety and tolerability of the combination of
Decitabine with Gemcitabine in previously treated patients with advanced pancreatic cancer
and advanced sarcoma and to define the recommended Phase II dose and describe the
dose-limiting toxicity of the combination of Decitabine with Gemcitabine. The preliminary
efficacy parameters of the combination of Decitabine with Gemcitabine will be estimated in
terms of response rate, disease control rate and progression-free survival.

Inclusion Criteria:

1. Patients must have metastatic histologically or cytologically confirmed pancreatic
adenocarcinoma or sarcoma (soft tissue or bone) for which progression was documented
for at least one line of therapy.

2. Age ≥18 years.

3. ECOG performance status ≤2 (Karnofsky ≥60% (See Appendix 1).

4. Life expectancy of greater than 3 months (does not apply to pancreatic cancer
population).

5. Measureable disease per RECIST criteria.

6. Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count ≥1,500/mm3

- Platelets ≥100 k/mm3

- Total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

- Creatinine
7. 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.

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.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Chemotherapy or radiotherapy within 4 weeks (for targeted therapies 5 half-lives)
prior to entering the study or failure to recover from adverse events due to agents
administered to physician.

2. Patients who are receiving any other investigational agents.

3. Known brain metastases.

4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Decitabine or other agents used in study.

5. Prior Decitabine for the treatment of this cancer. Patients with previous exposure to
therapy with Gemcitabine are allowed in the study.

6. 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.

7. Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C;
baseline testing for HIV and hepatitis C is not required.

8. Patients with any significant history of non-compliance to medical regimens or with
inability to grant a reliable informed consent.

9. 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.