Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasms, Unknown Primary

Neoplasm Metastasis

Neoplastic Processes

Patients of group 1 will be submitted to the standard conventional work-up (see below) as well as miRview™ mets assay. Their physician will treat the patient based upon both results

Patients of group 2 will be submitted to the standard conventional work-up. miRview™ mets assay will be performed but will remain blinded for both the patient and referring physician. Treatment will be decided based on standard work-up results

Salomon Shtemmer, MD

The aim of the study is in cancer of unknown primary (CUP) patients, to compare the cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary tumor site.

Thousands of patients are diagnosed each year with metastatic cancer; however, about 3-5% of them are diagnosed with Cancer of Unknown Primary (CUP). In order to identify the optimal treatment plan for individual patients with CUP, the primary tumor site must be identified. Patients undergo a wide range of costly, time-consuming, and inefficient tests to identify the primary site of origin, often to no avail.

In this era of targeted therapies, the accurate diagnosis of the primary tumor can be crucial. miRview™ mets is a new molecular diagnostic tool that identifies the tissue-of-origin of metastatic tumors, with 90% sensitivity.

Formalin Fixed Paraffin Embedded tumor tissue

Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)

An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel

To compare the cost-effectiveness of miRview™ mets test with conventional work-up in cancer of unknown primary (CUP) patients, by comparing total cost and time of the diagnostic process (including hospitalization time) from day 1 of the study to the decision on treatment program

1. Evaluating the miRview™ mets results based on the clinical and pathological work-up in all patients (retrospectively).
2. Evaluating the concordance between miRview™ mets result and the diagnosis obtained by the standard work-up process.
3. Comparing the response to treatment between study groups.
4. Comparing overall survival between study groups

Clalit Health Services

Rosetta Genomics

Teva Branded Pharmaceutical Products R&D, Inc.

Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Gemcitabine

Paclitaxel

Carboplatin

Irinotecan

Albumin-Bound Paclitaxel

Etoposide phosphate

Gefitinib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1

Carboplatin area under the curve (AUC) 6.0 IV, day 1

Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10

Regimen A was repeated at a 21-day interval

Irinotecan 100 mg/m2 IV, days 1 and 8

Gemcitabine 1000 mg/m2 IV, days 1 and 8

Regimen B was repeated at a 21-day interval

50 mg alternating with 100 mg PO, days 1 and 10 in regimen A

1000 mg/m2 IV, days 1 and 8, in regimen B

200 mg/m2 by 1-hour IV infusion, day 1, regimen A

Area under the curve (AUC) 6.0 IV, day 1, regimen A

John D. Hainsworth, MD

In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.

Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

* Paclitaxel + Carboplatin + Etoposide
* Irinotecan + Gemcitabine

Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site

Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease

AstraZeneca

Pharmacia and Upjohn

Eli Lilly and Company

SCRI Development Innovations, LLC

Paclitaxel/Carboplatin/Etoposide/Gefitinib

Irinotecan/Gemcitabine/Gefitinib

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

John Hainsworth, MD

Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Overall Study

Amino Acids

Bevacizumab

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Erlotinib

This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.

Upon determination of eligibility, patients will be receive:

* Bevacizumab + Erlotinib

Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Genentech, Inc.

Oxaliplatin

Capecitabine

All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.

1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle

In this phase II trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.

All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 PO BID was administered on days 1-14 of each cycle.

Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site

A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Roche Pharma AG

Sanofi-Synthelabo

Intervention

Progression Free Survival

Overall Survival

Oxaliplatin/Capecitabine

Neoplastic Cells, Circulating

Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP).

Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer.

Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

Patient stratification based on presence or absence of suspicious findings of cells and DNA

Circulating tumor cell and circulating tumor DNA test

Roland Soderholm, MD

Charlotta Savblom, MD, PhD

Christer Ericsson, PhD

Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies.

New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients.

Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA.

As a reference, germ-line DNA will also be sampled, also from regular blood samples.

The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced.

The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.

Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)

There is no plan to make individual participant data (IPD) available to other researchers

Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP?

Are the cellular and molecular sample analyses already practically useful for the universal confirmation or exclusion of the diagnosis of epithelial cancer, suggest from which anatomic location the cancer originated and predict individualised treatment, or should the test be re-focused on certain areas of diagnosis, or developed technically, in order to assist the diagnostic investigation and predict the treatment based on detailed information of the current state of the individual patient's disease?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)	NCT01202786	Neoplasms, Unkn...		18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)	NCT01202786	Neoplasms, Unkn...		18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site	NCT00193596	Neoplasms, Unkn...	Etoposide Gemcitabine Irinotecan Paclitaxel Carboplatin	18 Years -	SCRI Development Innovations, LLC
Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site	NCT00193622	Neoplasms, Unkn...	Bevacizumab Erlotinib	18 Years -	SCRI Development Innovations, LLC
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site	NCT00193609	Neoplasms, Unkn...	Oxaliplatin Capecitabine	18 Years -	SCRI Development Innovations, LLC
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site	NCT00193596	Neoplasms, Unkn...	Etoposide Gemcitabine Irinotecan Paclitaxel Carboplatin	18 Years -	SCRI Development Innovations, LLC
Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site	NCT00193622	Neoplasms, Unkn...	Bevacizumab Erlotinib	18 Years -	SCRI Development Innovations, LLC
Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP	NCT04025970	Neoplasms, Unkn... Cancer	Circulating tum...	18 Years - 125 Years	Region Stockholm
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site	NCT00193596	Neoplasms, Unkn...	Etoposide Gemcitabine Irinotecan Paclitaxel Carboplatin	18 Years -	SCRI Development Innovations, LLC
Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site	NCT00193622	Neoplasms, Unkn...	Bevacizumab Erlotinib	18 Years -	SCRI Development Innovations, LLC
Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP	NCT04025970	Neoplasms, Unkn... Cancer	Circulating tum...	18 Years - 125 Years	Region Stockholm

Spots Global Cancer Trial Database for neoplasms, unknown primary