Decitabine And Gemcitabine For Pancreatic Cancer And Sarcoma

Study Overview

Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma

The purpose of this Phase 1b study is to assess the safety and maximum tolerated dose (MTD) of Decitabine in combination with Gemcitabine among previously treated patients diagnosed with advanced pancreatic adenocarcinoma or sarcoma (soft tissue and bone).

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.

Pancreatic Ductal Adenocarcinoma
Sarcoma

DRUG: Decitabine
DRUG: Gemcitabine

201610750

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-11-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-07-25
First Submitted that Met QC Criteria 2016-11-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-28
First Posted (ACTUAL) 2016-11-08	Results First Posted N/A	Last Verified 2023-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Decitabine and Gemcitabine 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.	DRUG: Decitabine Dose escalation starting at 0.1mg/kg, subcutaneously administered on twice weekly schedule for three weeks of a 28 day cycle. Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 m DRUG: Gemcitabine Fixed infusion rate of 900 mg/m2, IV over 90 min, on Days, 1, 8 and 15 of a 28-day cycle. Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 mg/kg SQ twice weekly for 2 weeks; Le

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Decitabine and Gemcitabine

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.

DRUG: Decitabine

Dose escalation starting at 0.1mg/kg, subcutaneously administered on twice weekly schedule for three weeks of a 28 day cycle. Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 m

DRUG: Gemcitabine

Fixed infusion rate of 900 mg/m2, IV over 90 min, on Days, 1, 8 and 15 of a 28-day cycle. Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 mg/kg SQ twice weekly for 2 weeks; Le

Primary Outcome Measures	Measure Description	Time Frame
Dose Limiting Toxicity - To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients	Non-Hematologic - Any grade 3,4 solid organ toxicity not explainable by another cause in the opinion of the principal investigator	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
Tumor Response Rate - Change at evaluations	Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.	Change on two consecutive evaluations at least 8 weeks apart up to 30 days after the last date of any study therapy

Secondary Outcome Measures	Measure Description	Time Frame
Disease control rate (DCR)	DCR is defined as the proportion of patients who achieved a complete response (CR), partial response (PR) or stable disease (SD).	Patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy
Progression-free survival (PFS)	PFS is defined as the duration of time from start of treatment to time of progression or death due to any cause, whichever occurs first.	Patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy
Overall survival (OS)	OS is defined as the duration of time from start of treatment to death due to any cause.	Patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Holden Comprehensive Cancer Center
University of Iowa

Investigators

PRINCIPAL_INVESTIGATOR: Mohammed Milhem, MD, University of Iowa

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record