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Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959164
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Holden Comprehensive Cancer Center
University of Iowa
Information provided by (Responsible Party):
Varun Monga, University of Iowa

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Sarcoma Drug: Decitabine Drug: Gemcitabine Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study: Treatment of Refractory Pancreatic Adenocarcinoma and Advanced Soft Tissue or Bone Sarcomas Using Decitabine Combined With Gemcitabine
Study Start Date : December 2016
Actual Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 2020


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 mg/kg SQ twice weekly for 2 weeks; Level 1*: 0.1 mg/kg SQ twice weekly for 3 weeks; Level 2: 0.2 mg/kg SQ twice weekly for 3 weeks;

*Starting Dose Level

Other Name: Dacogen

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; Level 1*: 0.1 mg/kg SQ twice weekly for 3 weeks; Level 2: 0.2 mg/kg SQ twice weekly for 3 weeks;

*Starting Dose Level

Other Name: Gemzar




Primary Outcome Measures :
  1. Dose Limiting Toxicity - To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients [ Time Frame: 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 ]
    Non-Hematologic - Any grade 3,4 solid organ toxicity not explainable by another cause in the opinion of the principal investigator

  2. Tumor Response Rate - Change at evaluations [ Time Frame: Change on two consecutive evaluations at least 8 weeks apart up to 30 days after the last date of any study therapy ]

    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.



Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: Patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy ]
    DCR is defined as the proportion of patients who achieved a complete response (CR), partial response (PR) or stable disease (SD).

  2. Progression-free survival (PFS) [ Time Frame: Patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy ]
    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.

  3. Overall survival (OS) [ Time Frame: Patients will be evaluated weekly during each cycle of treatment up to 30 days after the last date of any study therapy ]
    OS is defined as the duration of time from start of treatment to death due to any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </= 1.5 ULN
  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 </= grade 1 or stable grade 2, at the discretion of the treating 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959164


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Varun Monga
Holden Comprehensive Cancer Center
University of Iowa
Investigators
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Principal Investigator: Varun Monga, MD University of Iowa
  Study Documents (Full-Text)

Documents provided by Varun Monga, University of Iowa:
Informed Consent Form  [PDF] October 10, 2019


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Responsible Party: Varun Monga, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02959164    
Other Study ID Numbers: 201610750
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Sarcoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Gemcitabine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs