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Anti-metabolites

Decitabine for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Mohammed Milhem, MD
Research Sponsored by Varun Monga, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining Decitabine with Gemcitabine to see if it is safe and effective.

Eligible Conditions
  • Pancreatic Cancer
  • Sarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have pancreatic cancer that has spread to other parts of your body or a specific type of bone or soft tissue cancer. You can join the study if you choose not to receive the standard first-line treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) up to 30 days after the last date of any study therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and all eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) up to 30 days after the last date of any study therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity - To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients
Tumor Response Rate - Change at evaluations
Secondary outcome measures
Disease control rate (DCR)
Overall survival (OS)
Progression-free survival (PFS)

Side effects data

From 2022 Phase 2 trial • 14 Patients • NCT04055844
57%
Neutrophil count decreased
57%
Febrile neutropenia
21%
Infections and infestations - Other, specify
21%
Lung infection
21%
Bacteremia
21%
Sepsis
14%
Infections and infestations - Other,
14%
Alanine aminotransferase increased
14%
Aspartate aminotransferase increased
7%
Encephalopathy
7%
Pericardial effusion
7%
Blood and lymphatic system
7%
Gastrointestinal disorders - Other, specify
7%
Injury, poisoning and procedural
7%
Hepatobiliary disorders
7%
INR increased
7%
Hepatic failure
7%
Alanine aminotransferase
7%
Sinusitis
7%
Neoplasms benign, malignant and
7%
Skin and subcutaneous tissue disorders - Other, specify
7%
White blood cell decreased
7%
Mucositis oral
7%
Hypertension
7%
Syncope
7%
General disorders and administration
7%
Disease progression
7%
Fever
7%
Intracranial hemorrhage
7%
Upper gastrointestinal hemorrhage
7%
Typhlitis
7%
Upper gastrointestinal
7%
Hepatic infection
7%
Hyperglycemia
7%
Gastrointestinal disorders - Other,
7%
Fatigue
7%
General disorders and administration site conditions - Other, specify
7%
Tooth infection
7%
Blood and lymphatic system disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Decitabine + Ruxolitinib + DLI

Trial Design

1Treatment groups
Experimental Treatment
Group I: Decitabine and GemcitabineExperimental Treatment2 Interventions
Decitabine, Dose escalation starting at 0.1mg/kg, subcutaneously administered on twice weekly schedule for three weeks of a 28 day cycle. Gemcitabine fixed infusion rate of 900 mg/m2, IV over 90 min, on Days, 1, 8 and 15 of a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
100 Total Patients Enrolled
Mohammed MilhemLead Sponsor
6 Previous Clinical Trials
108 Total Patients Enrolled
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
741 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this research project?

"At the moment, this medical research is not actively seeking new participants. Initially posted on December 1st 2016 and last updated on August 21th 2022, it has been concluded for now. However, there are 1234 sarcoma studies presently recruiting as well as 547 Decitabine clinical trials that may be of interest to explore."

Answered by AI

What medical conditions has Decitabine been known to address?

"Decitabine is commonly used to treat refractory anemia, as well as urinary bladder cancer, intermediate-2 risk category ipss and small cell lung carcinoma (sclc)."

Answered by AI

What safety profile does Decitabine possess?

"Limited data exists in regards to Decitabine's safety and efficacy, causing the medication to be assigned a score of 1."

Answered by AI

Are there any precedential investigations that have featured Decitabine?

"Currently, 547 clinical trials for Decitabine are underway with 149 in Phase 3. Numerous sites scattered across the world, including Woolloongabba Queensland, are running these studies; all together there are 26047 such locations."

Answered by AI

Are there remaining availabilities for participants in this research?

"According to clinicaltrials.gov, this medical trial is not currently in the process of enrolling patients. Initially posted on December 1st 2016 and last updated August 21st 2022, it is no longer recruiting; however there are 1781 other studies that remain actively seeking participants."

Answered by AI
~4 spots leftby Mar 2025