Overview
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.
Principal investigator
Eligibility criteria
Inclusion Criteria:
1. 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.
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 \
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 \
* 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 \
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 \
For Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.