Clinical Trials Logo

Clinical Trial Summary

This pilot clinical trial studies comprehensive gene sequencing in guiding treatment recommendations in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan treatment.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the feasibility and logistics associated with a clinical trial utilizing the Foundation Medicine Incorporated (FMI) test in an academic therapeutic setting. II. To determine the proportion of patients who will receive a cancer-related therapy based on the results provided by the FMI test. SECONDARY OBJECTIVES: I. To explore and report estimates of progression free survival (PFS) of the regimen administered after the FMI test results are revealed and the PFS of the most recent regimen administered before the FMI test results were received. II. To determine the feasibility of performing Next Generation Sequencing (NGS) on metastatic tumor tissue. III. To determine the feasibility of administering cancer-related drugs that are proposed by the results of NGS that are not Food and Drug Administration (FDA)-approved for a patient's specific cancer diagnosis. IV. To collect and report the molecular alterations discovered by NGS of advanced breast and colorectal cancer. V. To determine in an exploratory manner the concordance of the genomic alterations detected by the FMI test in circulating tumor cells (CTCs) to the genomic alterations detected by FMI test in tumor tissues collected from the same patient. OUTLINE: PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples and CTCs from patients are collected for NGS and FMI testing, respectively. Patients remain on current line of therapy until a change in treatment is warranted. The physician's treatment recommendation is documented prior to the release of the FMI results. PART II: Physicians are furnished with FMI test results when patients become eligible for a change in therapy and new treatment recommendations are documented. Treatment is dependent on preferences of the physician, patient, and/or results of the FMI test. After completion of study, patients are followed up for at least 18 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01987726
Study type Observational
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase
Start date September 3, 2013
Completion date June 28, 2021

See also
  Status Clinical Trial Phase
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Completed NCT00602043 - F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer Phase 2
Completed NCT00244881 - A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202) Phase 2
Completed NCT00100750 - Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT00096109 - Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer Phase 2
Completed NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/Phase 2
Completed NCT00096434 - Sorafenib in Treating Patients With Metastatic Breast Cancer Phase 2
Completed NCT00057941 - Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer Phase 2
Terminated NCT02892734 - Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer Phase 2
Recruiting NCT03213041 - Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer Phase 2
Completed NCT02015559 - Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus Phase 2
Completed NCT02728596 - S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) N/A
Completed NCT03364348 - 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer Phase 1
Completed NCT02897375 - Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors Phase 1
Completed NCT01672684 - Phase I: At-Home Support for Rural Women Using Group Video Calling Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT01149356 - RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer Phase 1