None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate the usefulness of the FoundationOne(Registered Trademark) genetic profiling test for patients diagnosed with cancer of unknown primary, a cancer where the location of the cancer cannot yet be found. Who is it for? Patients may be eligible to participate in this study if they are aged 18 years or over and have been diagnosed with metastatic or advanced unresectable cancer of unknown primary. In order to complete the FoundationOne (Registered Trademark) testing, study participants must have adequate tissue available from a tumour biopsy. Study details All participants in this study will receive the FoundationOne(Registered Trademark) test. This test involves testing cancer cells from a sample of tumour tissue obtained during a biopsy. The results of the test will be discussed between each study participant and his/her treating physician, along with results from any other diagnostic tests performed, and a treatment plan will be agreed upon. The results of the FoundationOne(Registered Trademark) test may provide information that could help physicians decide which treatment could be the most beneficial in treating cancer of unknown primary. Physicians will follow study participants approximately every 3 months and provide information about study participants’ status and treatment. The purpose of collecting the Information from the FoundationOne(Registered Trademark) test and the results of the patients’ treatment(s) is to learn about the usefulness of the FoundationOne(Registered Trademark) test results for decision-making by treating physicians.
Interventions
This is a prospective, single arm observational study of FoundationOne (Registered Trademark) -directed targeted therapy in newly diagnosed and previously treated patients with CUP. Patients will be consented and have FoundationOne (Registered Trademark) comprehensive molecular profiling completed. Other molecular assays are permitted for treatment assignment, but adequate tumor tissue must remain to perform FoundationOne (Registered Trademark). FoundationOne (Registered Trademark) profiling is
This is a prospective, single arm observational study of FoundationOne (Registered Trademark) -directed targeted therapy in newly diagnosed and previously treated patients with CUP. Patients will be consented and have FoundationOne (Registered Trademark) comprehensive molecular profiling completed. Other molecular assays are permitted for treatment assignment, but adequate tumor tissue must remain to perform FoundationOne (Registered Trademark). FoundationOne (Registered Trademark) profiling is required as part of this study. If the FoundationOne (Registered Trademark) has not already been conducted, a tissue sample from the patient’s biopsy will be sent to Foundation Medicine for testing. Adequate tumor tissue must remain to confirm genomic alterations in enrolled patients. Results from the FoundationOne (Registered Trademark) may provide information about patients’ cancer that may help physicians make decisions about patients’ treatment. Previous FoundationOne (Registered Trademark) profiling is also allowed and is not required to be repeated. All patients will be followed approximately every 3 months until death. Upon distribution of the results, physicians will decide with patients the appropriate treatment regimen. Patients may be treated on clinical trials of targeted therapies or may receive TGA approved therapies, including “off-label” agents, as available.
Sponsors
Foundation Medicine, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological or cytological confirmed diagnosis of metastatic or advanced unresectable CUP 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 unknown primary available for FoundationOne (Registered Trademark) testing. 4. First and second line patients must have an ECOG Status score of 0 to 2. Third line patients enrolling in this study must have an ECOG Status score of 0 to 1. 5. Measurable or evaluable disease per RECIST version 1.1 6. Patients are considered potential candidates for treatment with targeted therapy. 7. Willingness and ability to comply with study and follow-up procedures. 8. Ability to understand the nature of this study and give written informed consent. 9. 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 nonmelanoma skin cancer.
Exclusion criteria
1. Received three or more lines of prior therapy for CUP. 2. Previously received matched targeted therapy for the same Class 1 alteration or the same drug. 3. Treatable CUP syndrome, including the following: a. extragonadal germ cell syndrome, b. neuroendocrine carcinoma, c. adenocarcinoma isolated to axillary lymph nodes (women), d. peritoneal carcinomatosis (women), e. squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes, and f. single resectable metastasis. 4. Previously untreated brain metastases. Patients who have received radiation or surgery or 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. 5. Enzyme inducing anticonvulsants 6. Pregnant or lactating. 7. Psychological, familial, sociologic, or geographic conditions that do not permit compliance with the protocol.
Outcome results
None listed