Outcomes of FoundationOne Directed Therapy in Cancer of Unknown Primary

July 9, 2018 updated by: Foundation Medicine

A Prospective Observational Trial Evaluating Outcomes of FoundationOne - Directed Matched Targeted Therapy in Patients With Cancer of Unknown Primary (CUP)

The goal of the current study is to determine whether Foundation Medicine's next generation sequencing assay, called FoundationOne, will provide information that allows physicians to make treatment decisions using targeted therapies in clinical trials or FDA approved therapies, including "off-label" agents, that result in superior OS compared to historical outcomes for standard CUP therapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02141
        • Foundation Medicine, Inc

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed and previously treated patients with CUP.

Description

Inclusion Criteria:

  1. Patients with a histologically or cytologically confirmed diagnosis of metastatic or advanced unresectable cancer of unknown primary including adenocarcinoma, poorly differentiated adenocarcinoma, poorly differentiated carcinoma, or squamous carcinoma.
  2. To be categorized as CUP, the following clinical evaluations must have been performed without identification of an anatomic primary site: medical history, physical examination, chemistry profile, blood counts, serum PSA (men), CT scans of chest/abdomen/pelvis, specific evaluation of symptomatic areas.
  3. Sufficient Formalin Fixed Paraffin Embedded tissue from cancer of study will allow previously completed profiling panels other than for treatment assignment; however, FoundationOne profiling is required as part of this study. Adequate tumor tissue must remain, in the estimate of the consenting physician, to confirm genomic alterations in enrolled patients. Previous unknown primary available for FoundationOne testing. (Note: This FoundationOne® profiling is also allowed and is not required to be FoundationOne repeated.) (see Appendix A and Appendix B)
  4. First and second line patients enrolling in this study must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2. Third line patients enrolling in this study must have an ECOG Performance Status score of 0 to 1 (Appendix C).
  5. Patients must have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Appendix D).
  6. Age greater than or equal to 18 years.
  7. Patients are considered potential candidates for treatment with targeted therapy.
  8. Willingness and ability to comply with study and follow-up procedures.
  9. Ability to understand the nature of this study and give written informed consent.
  10. The presence of other active cancers is not allowed, unless indolent and not requiring therapy. Patients with early stage cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.

Exclusion Criteria:

  1. Patients who have received three or more lines of systemic therapy for cancer of unknown primary.
  2. Patients who have previously received matched targeted therapy for the same Class 1 alteration (see Table 1) or the same drug.

  3. Patients with treatable CUP syndrome, including the following:

    • extragonadal germ cell syndrome
    • neuroendocrine carcinoma
    • adenocarcinoma isolated to axillary lymph nodes (women)
    • peritoneal carcinomatosis (women)
    • squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
    • single resectable metastasis
  4. Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy. Enzyme-inducing anticonvulsants are contraindicated.
  5. Pregnant or lactating.
  6. Psychological, familial, sociologic, or geographic conditions that do not permit compliance with the protocol.

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Class 1, 2, or 3 alterations, with targeted therapy
Patients put on targeted therapies matched to specific genomic alterations.
Site-specific therapy determined by tissue of origin testing
Patients put on therapy determined by tissue of origin testing (e.g., CancerTYPE ID)
Empiric CUP therapy
Patients put on empiric treatment at physician discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of CUP patients who receive matched targeted therapy.
Time Frame: Baseline visit
Baseline visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS) in CUP patients receiving matched targeted therapy based on FoundationOne versus internal control CUP patients not receiving FoundationOne-directed therapy
Time Frame: Every three months until death, [20 months]
Every three months until death, [20 months]

Collaborators and Investigators

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

Sponsor

Foundation Medicine

Collaborators

The Cleveland Clinic
Rush University Medical Center
St. Luke's Hospital and Health Network, Pennsylvania
Stormont-Vail Healthcare
Jefferson Medical College of Thomas Jefferson University
Sparrow Health System
Cancer & Hematology Centers of Western Michigan (CHCWM)
Allegheny Health Network
Solano Hematology Oncology
Horizon Oncology Center
Comprehensive Blood and Cancer Center
Lancaster Cancer Center
Western Maryland Health Center
Valley Medical Oncology
Cape Fear Valley Health System
Tri-County Hematology Oncology
Hematology & Oncology Associates
Broome Oncology
Orchard Healthcare
Ashland Bellefonte Cancer Center
Tennessee Cancer Specialists
North Shore Hematology Oncology
Good Samaritan
Zangmeister Cancer Center
Watson clinic
Oncology Consultants
Oncology Hematology Care
Northern Westchester Hospital
Peter MacCallum Cancer Center Trials Unit

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAP-CLT-15-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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