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Trial record 11 of 874 for:    Pancreatic Cancer AND Progression-free survival

Molecularly Tailored Therapy to Standard of Care as Second-Line Therapy in Metastatic Pancreatic Cancer (PanCAN)

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ClinicalTrials.gov Identifier: NCT02967770
Recruitment Status : Withdrawn (Issues with patient recruitment.)
First Posted : November 18, 2016
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Thomas Jefferson University
Sinai Health System
Virginia Mason Hospital/Medical Center
Cedars-Sinai Medical Center
George Mason University
Caris Life Sciences, Inc
Theranostics Health, Inc
Guardant Health, Inc.
Companion Diagnostics, Inc.
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
The purpose of this study is to determine whether molecularly tailored therapy can improve the efficacy of treatment when compared to standard chemotherapy combinations for patients with metastatic pancreatic cancer receiving their second line of therapy for metastatic disease.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Other: Molecularly Tailored Second Line Therapy Drug: Standard of Care Second Line Therapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Comparing Molecularly Tailored Therapy to Physician's Discretion Standard of Care as Second-Line Therapy for Patients With Metastatic Pancreatic Cancer
Actual Study Start Date : November 2016
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Molecularly Tailored Therapy
Patients will be treated according to their molecular profile and accordingly, the 29 evaluable patients enrolled may receive one of a dozen, or dozens of treatment regimens.
Other: Molecularly Tailored Second Line Therapy
This trial is designed to assess the efficacy of MTT vs. SOC therapy as second-line therapy in patients with metastatic pancreatic cancer.

Active Comparator: Physician's Discretion Standard of Care
Patients will be treated according to physician discretion standard of care regimen.
Drug: Standard of Care Second Line Therapy



Primary Outcome Measures :
  1. 4 month progression free survival rate [ Time Frame: 4 months after treatment start ]
    4 month progression free survival rate (PFS4mos) of MTT vs. SOC therapy as second line therapy in patients with metastatic pancreatic cancer


Secondary Outcome Measures :
  1. Median overall survival [ Time Frame: 60 months ]
  2. Objective Response Rate [ Time Frame: 60 months ]
  3. Disease control rate [ Time Frame: 6 months ]
    Disease Control Rate (DCR) = Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) at 6 months

  4. Median progression-free survival [ Time Frame: 60 months ]
  5. Change in tumor marker levels [ Time Frame: 60 months ]
    Cancer Antigen (CA) 19-9 or Carcinoembryonic antigen (CEA)



Information from the National Library of Medicine

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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. Histologically confirmed metastatic adenocarcinoma of the pancreas (at enrollment)
  2. Actively on (or about to initiate) first line therapy for metastatic pancreatic cancer (at enrollment)

    • Patients may have had neo-adjuvant and/or chemotherapy that must have been completed >3 months prior to starting first line therapy
    • Patients may be actively on "maintenance" therapy, such as maintenance capecitabine up to starting first line therapy for metastatic disease
  3. Radiographically measurable disease (prior to initiation of second-line therapy)
  4. Tumor deposits that are clearly accessible for serial tumor biopsies - A patient's biopsied lesion must be at least 1cm in diameter (in at least one dimension) (prior to initiation of second-line therapy)
  5. Age ≥ 18 years (at enrollment)
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Table 6, Appendix D) (at enrollment)
  7. Adequate hepatic, bone marrow, and renal function at the time of enrollment AND at initiation of second line therapy:

    • Bone Marrow: Absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 9.0 g/dL
    • Patients may have a transfusion of red blood cells to meet the hemoglobin requirement
    • Renal function: Serum creatinine ≤ 1.5 X upper normal limit of institution's normal range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
    • Hepatic function: Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X the upper normal limit of institution's normal range; bilirubin ≤ 1.5 X the upper limit of normal. For patients with known hepatic metastases, AST and ALT ≤ 5 X the upper normal limit of institution's normal range
    • Prothrombin Time and Partial Thromboplastin Time (PTT) must be ≤ 2 X the upper limit of the institution's normal range and International Normalized Ratio (INR) < 2. Subjects on anticoagulation (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator
  8. Patients must have fully recovered from all effects of surgery (prior to initiation of second-line therapy). Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring "Twilight" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator.
  9. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential (at enrollment).
  10. Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures (at enrollment).

Exclusion Criteria:

  1. Known or suspected brain or central nervous system metastases, irrespective of prior treatment
  2. The subject has had another active malignancy within the past three years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. Questions regarding the inclusion of individual subjects should be directed to the Study Chair.
  3. Clinically significant peripheral neuropathy at the time of enrollment (defined in the NCI Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)
  4. Patients receiving any other investigational agents.
  5. Active severe infection, or known chronic infection with HIV or hepatitis B virus

    -Patients with chronic Hepatitis C virus may be enrolled if there is no clinical/laboratory evidence of cirrhosis AND the patient's liver function tests fall within the parameters set in Section 3.2.7.3, Inclusion Criteria, Hepatic function

  6. Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke within the last 3 months, or a diagnosis of congestive heart failure
  7. Life-threatening visceral disease or other severe concurrent disease
  8. Women who are pregnant or breastfeeding
  9. Anticipated patient survival under 2 months

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): NCT02967770


Locations
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United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Thomas Jefferson University
Sinai Health System
Virginia Mason Hospital/Medical Center
Cedars-Sinai Medical Center
George Mason University
Caris Life Sciences, Inc
Theranostics Health, Inc
Guardant Health, Inc.
Companion Diagnostics, Inc.
Investigators
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Study Chair: Michael Pishvaian, MD, PhD Georgetown Lombardi Comprehensive Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02967770     History of Changes
Other Study ID Numbers: 2015-1120
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Georgetown University:
Metastatic
Pancreas
Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases