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

NCT02967770 | Withdrawn Phase 2 DMC

• 1 other identifier: 2015-1120
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Cancer

Keywords

Metastatic; Pancreas; Cancer

Outcome Measures

Primary Outcomes (1)

• 4 month progression free survival rate

  4 month progression free survival rate (PFS4mos) of MTT vs. SOC therapy as second line therapy in patients with metastatic pancreatic cancer

  4 months after treatment start

Secondary Outcomes (5)

• Median overall survival

  60 months

• Objective Response Rate

  60 months

• Disease control rate

  6 months

• Median progression-free survival

  60 months

• Change in tumor marker levels

  60 months

Study Arms (2)

Molecularly Tailored Therapy

EXPERIMENTAL

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

Physician's Discretion Standard of Care

ACTIVE COMPARATOR

Patients will be treated according to physician discretion standard of care regimen.

Drug: Standard of Care Second Line Therapy

Interventions

Molecularly Tailored Second Line Therapy OTHER

This trial is designed to assess the efficacy of MTT vs. SOC therapy as second-line therapy in patients with metastatic pancreatic cancer.

Molecularly Tailored Therapy

Standard of Care Second Line Therapy DRUG

Physician's Discretion Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic adenocarcinoma of the pancreas (at enrollment)
• 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
• Radiographically measurable disease (prior to initiation of second-line therapy)
• 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)
• Age ≥ 18 years (at enrollment)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Table 6, Appendix D) (at enrollment)
• 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
• 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.

You may not qualify if:

• Known or suspected brain or central nervous system metastases, irrespective of prior treatment
• 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)
• Patients receiving any other investigational agents.
• Active severe infection, or known chronic infection with HIV or hepatitis B virus
• 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
• Life-threatening visceral disease or other severe concurrent disease
• Women who are pregnant or breastfeeding
• Anticipated patient survival under 2 months

Sponsors & Collaborators

• Georgetown University: lead
• Thomas Jefferson University: collaborator
• Sinai Health System: collaborator
• Virginia Mason Hospital/Medical Center: collaborator
• Cedars-Sinai Medical Center: collaborator
• George Mason University: collaborator
• Caris Life Sciences: collaborator
• Theranostics Health, Inc: collaborator
• Guardant Health, Inc.: collaborator
• Companion Diagnostics, Inc.: collaborator

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• Tesfaye AA, Wang H, Hartley ML, He AR, Weiner L, Gabelia N, Kapanadze L, Shezad M, Brody JR, Marshall JL, Pishvaian MJ. A Pilot Trial of Molecularly Tailored Therapy for Patients with Metastatic Pancreatic Ductal Adenocarcinoma. J Pancreat Cancer. 2019 May 2;5(1):12-21. doi: 10.1089/pancan.2019.0003. eCollection 2019.

  PMID: 31065624 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Pishvaian, MD, PhD

  Georgetown Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)