This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.
The primary objective of the study is evaluate the impact of the molecular assay prediction on the efficacy of therapy for patients with carcinoma of unknown primary site (CUP). Investigators will use tumor profiling results to direct standard, site-specific first-line therapy for patients with CUP.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
289
175 mg/m2, 1-3 hour IV infusion Day 1
AUC 6.0 IV Day 1
15 mg/kg IV infusion Day 1
150 mg PO
Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy
Oncology Specialties (Clearview Cancer Institute)
Huntsville, Alabama, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Wellstar Cancer Research
Marietta, Georgia, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Baptist Hospital East
Louisville, Kentucky, United States
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, United States
...and 11 more locations
Overall Survival
Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.
Time frame: every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months
Number of Participants With a Tissue of Origin Successfully Predicted by the Assay
To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.
Time frame: at baseline
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